ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Brazil
Netherlands
Spain
France
Belgium
Russian Federation
Portugal
Denmark
Germany

acronym: TRISTARDS

location_facility: City Clinical Hospital # 40 of the Moscow Health Department

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Wiener Gesundheitsverbund Klinik Favoriten

location_facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

location_facility: Klinikum der Universität München - Campus Großhadern

title: The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19.

summary:
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster.

The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment.

Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month.

Participants are in the study for 3 months.


design_allocation: Randomized

intervention_type: Radiation

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Italy
United States
South Africa
Mexico
Spain
France
Japan
Lithuania
Hungary
Belgium
Australia
Russian Federation
China
Estonia
Turkey
Canada
United Kingdom
Korea, Republic of
Ukraine

location_facility: Daping Hospital,Third Military Medical University ( Site 3136)

location_facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1312)

location_facility: Medipol Universite Hastanesi ( Site 2005)

location_facility: Hospital Universitario Central de Asturias ( Site 1900)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 3303)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1509)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 2201)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

location_facility: Okayama University Hospital ( Site 4012)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)

location_facility: Loma Linda University Cancer Center ( Site 0011)

location_facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)

location_facility: Gold Coast University Hospital ( Site 3003)

location_facility: Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)

location_facility: Institut De Cancerologie De L Ouest ( Site 1110)

location_facility: Aichi Cancer Center Hospital ( Site 4010)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0069)

location_facility: Kansai Medical University Hospital ( Site 4009)

location_facility: Istituto Nazionale dei Tumori ( Site 1504)

location_facility: Nacionalinis Vezio Institutas ( Site 2300)

location_facility: Peking University Shenzhen Hospital ( Site 3118)

location_facility: Second Xiangya Hospital of Central-South University ( Site 3128)

location_facility: Policlinico Universitario Agostino Gemelli ( Site 1505)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 1807)

location_facility: Saint Francis Cancer Center ( Site 0087)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0034)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 4007)

location_facility: Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0056)

location_facility: Istituto Europeo di Oncologia ( Site 1501)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 4011)

location_facility: Keimyung University Dongsan Hospital ( Site 3302)

location_facility: The Second Affiliated Hospital of Nanchang University ( Site 3106)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)

location_facility: Ironwood Cancer & Research Centers ( Site 0007)

location_facility: Severance Hospital Yonsei University Health System ( Site 3304)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0045)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)

location_facility: VA Ann Arbor Healthcare System ( Site 0050)

location_facility: Western Health-Sunshine Hospital ( Site 3004)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1806)

location_facility: Seoul National University Bundang Hospital ( Site 3301)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 1506)

location_facility: Shandong Province Cancer Hospital ( Site 3100)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 2200)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)

location_facility: Multicare Institute For Research And Innovation ( Site 0108)

location_facility: Hospital Universitari Vall d Hebron ( Site 1904)

location_facility: Penn State Hershey Cancer Institute ( Site 0081)

location_facility: Providence Regional Cancer Partnership ( Site 0106)

location_facility: CHU UCL Namur Site de Godinne ( Site 1004)

location_facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)

location_facility: Tudogyogyintezet Torokbalint ( Site 1304)

location_facility: Zhejiang Cancer Hospital.... ( Site 3108)

location_facility: National Cancer Center Hospital ( Site 4015)

location_facility: West China Hospital of Sichuan University ( Site 3114)

location_facility: IRCCS Ospedale San Raffaele ( Site 1500)

location_facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)

location_facility: Steve Biko Academic Hospital ( Site 5000)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 3007)

location_facility: Hospital Regional Universitario de Malaga ( Site 1905)

location_facility: The Cancer Institute Hospital of JFCR ( Site 4006)

location_facility: Shanghai Pulmonary Hospital ( Site 3101)

location_facility: Clinic of National Cancer Institute ( Site 2101)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 4000)

location_facility: Inje University Haeundae Paik Hospital ( Site 3307)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

location_facility: Kyiv City Clinical Oncology Center ( Site 2100)

location_facility: Juntendo University Hospital ( Site 4008)

location_facility: Austin Health-Austin Hospital ( Site 3006)

location_facility: Fujian Provincial Cancer Hospital ( Site 3126)

location_facility: Orszagos Onkologiai Intezet ( Site 1310)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)

location_facility: Osaka International Cancer Institute ( Site 4005)

location_facility: Xiangya Hospital of Central South University ( Site 3137)

location_facility: Tongji Medical College Huazhong University of Science and Technology ( Site 3138)

location_facility: A O U Policlinico di Modena ( Site 1503)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0123)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0093)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3103)

location_facility: The First Hospital of Jilin University ( Site 3132)

location_facility: Ninewells Hospital and Medical School ( Site 2401)

location_facility: Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 4003)

location_facility: Hospital Universitario 12 de Octubre ( Site 1902)

location_facility: Peking Union Medical College Hospital ( Site 3102)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)

location_facility: Niigata Cancer Center Hospital ( Site 4004)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 3121)

location_facility: The University of Tennessee Medical Center ( Site 0116)

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: Other Identifier

type: EudraCT Number

type: Registry Identifier

source: euctr

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

summary:
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).

Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.

Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11.

family: Ginsburg

full_name: Amy Sarah Ginsburg

given: Amy Sarah

sequence: first

family: Srikantiah

full_name: Padmini Srikantiah

given: Padmini

sequence: additional

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Global Health

oa_host_type: publisher

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Drug

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

primary_purpose: Prevention

location_country:
Finland
Belgium
Australia
Taiwan
India
France
Panama
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Philippines
United States
United Kingdom
Italy
Brazil
Mexico
Bangladesh
New Zealand
Spain

acronym: GRACE

title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age

summary: The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.


title: A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction (LYNK-003)

summary: This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR.

ReferenceCitation: Kim TW, Taieb J, Gurary EB, Lerman N, Cui K, Yoshino T. Olaparib with or without bevacizumab or bevacizumab and 5-fluorouracil in advanced colorectal cancer: Phase III LYNK-003. Future Oncol. 2021 Nov 15. doi: 10.2217/fon-2021-0899. [Epub ahead of print]

name: Department of Oncology, Asan Medical Center, University of Ulsan, Seoul 05505, South Korea

family: Kim

full_name: Tae Won Kim

given: Tae Won

name: Georges Pompidou European Hospital, SIRIC-CARPEM, Université de Paris, Paris 75015, France

family: Taieb

full_name: Julien Taieb

given: Julien

name: Oncology Late Stage Development, Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Gurary

full_name: Ellen B Gurary

given: Ellen B

family: Lerman

full_name: Nati Lerman

given: Nati

name: Late Development Oncology, Oncology R&D, AstraZeneca, Gaithersburg, MD 20878, USA

family: Cui

full_name: Karen Cui

given: Karen

name: Department of Gastrointestinal Medicine, National Cancer Center Hospital East, Kashiwa 277-8577, Japan

family: Yoshino

full_name: Takayuki Yoshino

given: Takayuki

journal_name: Future Oncology

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

location_country:
United States
Chile
South Africa
Germany
France
Japan
Lithuania
Hungary
Belgium
Australia
Russian Federation
Spain
Turkey
Canada
Latvia
Korea, Republic of
Colombia
Ukraine

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0353)

location_facility: St. Josef und St. Elisabeth Hospital gGmbH-Hematology, oncology and palliative medicine ( Site 0503)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1314)

location_facility: CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0457)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0360)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 1526)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0455)

location_facility: Orszagos Onkologiai Intezet ( Site 1431)

location_facility: James Graham Brown Cancer Center ( Site 1393)

location_facility: Riga East Clinical University Hospital ( Site 1501)

location_facility: Providence Portland Medical Center ( Site 1400)

location_facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1128)

location_facility: Hospital General Universitario de Elche ( Site 1155)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0201)

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1204)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 1207)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1127)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)

location_facility: Korea University Anam Hospital ( Site 0955)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0655)

location_facility: Hacettepe University Faculty of Medicine ( Site 1200)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0657)

location_facility: Administradora Country SA - Clinica del Country ( Site 0350)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1429)

location_facility: Dr. Everett Chalmers Regional Hospital ( Site 0204)

location_facility: Providence Saint Joseph Medical Center, Disney Family Cancer ( Site 1392)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1130)

location_facility: Baskent University Adana Training Hospital ( Site 1205)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 1317)

location_facility: McGill University Health Centre ( Site 0207)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1113)

location_facility: University Cancer & Blood Center, LLC ( Site 1381)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1121)

location_facility: Nacionalinis Vezio Institutas ( Site 1527)

location_facility: Hopital Cite de la Sante de Laval ( Site 0203)

location_facility: Allegheny Singer Research Institute ( Site 1364)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0654)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0252)

location_facility: Oregon Health & Science University ( Site 1411)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0362)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1202)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1427)

location_facility: National Cancer Center Hospital ( Site 0651)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1319)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0202)

location_facility: Hospital Universitario Central de Asturias ( Site 1153)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0956)

location_facility: Cancer Partners of Nebraska ( Site 1353)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 0953)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 1358)

location_facility: Aichi Cancer Center Hospital ( Site 0658)

location_facility: Poudre Valley Health System ( Site 1402)

location_facility: Hopital Europeen Georges Pompidou ( Site 0452)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0251)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0659)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0900)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1426)

location_facility: City Clinical Oncology Center ( Site 1114)

location_facility: Severance Hospital Yonsei University Health System ( Site 0951)

location_facility: Royal Brisbane and Women s Hospital ( Site 0054)

location_facility: Princess Margaret Cancer Centre ( Site 0209)

location_facility: Seoul National University Hospital ( Site 0950)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1152)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1214)

location_facility: Daugavpils Regional Hospital ( Site 1502)

location_facility: Washington University in St. Louis ( Site 1384)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1203)

location_facility: Medical Center Asklepion LLC ( Site 1309)

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1129)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1215)

location_facility: West Cancer Center - East Campus ( Site 1396)

location_facility: Prof. Dr. Cemil Tascioglu Sehir Hastanesi ( Site 1216)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 1321)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 1210)

location_facility: UC Health Memorial Hospital ( Site 1401)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1304)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 1126)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 1397)

location_facility: Kartal Dr. Lutfi Kirdar Egitim ve Arast Hast ( Site 1211)

location_facility: University Medical Center New Orleans ( Site 1365)

location_facility: Peninsula Health Frankston Hospital ( Site 0056)

location_facility: St. Joseph Heritage Healthcare ( Site 1383)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 1432)

location_facility: Cancercare Rondebosch Oncology ( Site 0904)

location_facility: P. Stradina Clinical University Hospital ( Site 1500)

location_facility: Hospital 12 de Octubre de Madrid ( Site 1150)

location_facility: Vanderbilt University Medical Center ( Site 1362)

location_facility: C.H.U. de Strasbourg Hopital de Hautepierre ( Site 0464)

location_facility: National Cancer Center Hospital East ( Site 0650)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0652)


title: A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.

summary: The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Guatemala
Philippines
Germany
France
Bulgaria
Czechia
Japan
Poland
Slovakia
Hungary
Belgium
Argentina
Russian Federation
Canada
Latvia
Korea, Republic of


ReferenceCitation: Lescure FX, Honda H, Fowler RA, Lazar JS, Shi G, Wung P, Patel N, Hagino O; Sarilumab COVID-19 Global Study Group. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 May;9(5):522-532. doi: 10.1016/S2213-2600(21)00099-0. Epub 2021 Mar 4.

family: Lescure

full_name: François-Xavier Lescure

given: François-Xavier

family: Honda

full_name: Hitoshi Honda

given: Hitoshi

family: Fowler

full_name: Robert A Fowler

given: Robert A

family: Lazar

full_name: Jennifer Sloane Lazar

given: Jennifer Sloane

family: Shi

full_name: Genming Shi

given: Genming

family: Wung

full_name: Peter Wung

given: Peter

family: Patel

full_name: Naimish Patel

given: Naimish

family: Hagino

full_name: Owen Hagino

given: Owen

family: Bazzalo

full_name: Ignacio J. Bazzalo

given: Ignacio J.

family: Casas

full_name: Marcelo M. Casas

given: Marcelo M.

family: Nuñez

full_name: Sebastián A. Nuñez

given: Sebastián A.

family: Pere

full_name: Yael Pere

given: Yael

family: Ibarrola

full_name: Carlos M. Ibarrola

given: Carlos M.

family: Solis Aramayo

full_name: Marco A. Solis Aramayo

given: Marco A.

family: Cuesta

full_name: Maria C. Cuesta

given: Maria C.

family: Duarte

full_name: Andrea E. Duarte

given: Andrea E.

family: Gutierrez Fernandez

full_name: Pablo M. Gutierrez Fernandez

given: Pablo M.

family: Iannantuono

full_name: Maria A. Iannantuono

given: Maria A.

family: Miyazaki

full_name: Erica A. Miyazaki

given: Erica A.

family: Silvio

full_name: Javier P. Silvio

given: Javier P.

family: Scublinsky

full_name: Dario G. Scublinsky

given: Dario G.

family: Bales

full_name: Alessandra Bales

given: Alessandra

family: Catarino

full_name: Daniela Catarino

given: Daniela

family: Fiss

full_name: Elie Fiss

given: Elie

family: Mohrbacher

full_name: Sara Mohrbacher

given: Sara

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

location_country:
Italy
Brazil
Chile
Germany
France
Japan
Israel
Argentina
Russian Federation
Spain
Canada

location_facility:
Investigational Site Number 3800001
Investigational Site Number 3800005
Investigational Site Number 3800003
Investigational Site Number 2760004
Investigational Site Number 1240001
Investigational Site Number 3920003
Investigational Site Number 0760003
Investigational Site Number 2500002
Investigational Site Number 3920001
Investigational Site Number 7240003
Investigational Site Number 7240002
Investigational Site Number 1240002
Investigational Site Number 2500003
Investigational Site Number 1520002
Investigational Site Number 3800006
Investigational Site Number 1240004
Investigational Site Number 0760001
Investigational Site Number 3800002
Investigational Site Number 2760001
Investigational Site Number 3760001
Investigational Site Number 3800004
Investigational Site Number 6430003
Investigational Site Number 0320004
Investigational Site Number 6430001
Investigational Site Number 2500001
Investigational Site Number 1520004
Investigational Site Number 2500004
Investigational Site Number 2760002
Investigational Site Number 2500006
Investigational Site Number 7240004
Investigational Site Number 0760005
Investigational Site Number 3920002
Investigational Site Number 0760004
Investigational Site Number 7240005
Investigational Site Number 0320001
Investigational Site Number 0320003
Investigational Site Number 1520001
Investigational Site Number 1240003
Investigational Site Number 7240001
Investigational Site Number 3760002
Investigational Site Number 2500007
Investigational Site Number 6430002
Investigational Site Number 1240005
Investigational site number 3760003
Investigational Site Number 0760002
Investigational Site Number 2500005
Investigational Site Number 1520003

title: An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19

summary:
Primary Objective:

To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19).

Secondary Objectives:

Evaluate the 28-day survival rate.
Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity.
Evaluate changes in the National Early Warning Score 2.
Evaluate the duration of predefined symptoms and signs (if applicable).
Evaluate the duration of supplemental oxygen dependency (if applicable).
Evaluate the incidence of new mechanical ventilation use during the study.
Evaluate the duration of new mechanical ventilation use during the Study.
Evaluate the proportion of participants requiring rescue medication during the 28-day period.
Evaluate need for admission into intensive care unit.
Evaluate duration of hospitalization (days).

The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of:

Serious adverse events.
Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia.
Grade greater than or equal to (>=) 2 infusion related reactions.
Grade >=2 hypersensitivity reactions.
Increase in alanine transaminase (ALT) >=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline).
Major or opportunistic bacterial or fungal infections.


ReferenceCitation: Rosas IO, Bräu N, Waters M, Go RC, Hunter BD, Bhagani S, Skiest D, Aziz MS, Cooper N, Douglas IS, Savic S, Youngstein T, Del Sorbo L, Cubillo Gracian A, De La Zerda DJ, Ustianowski A, Bao M, Dimonaco S, Graham E, Matharu B, Spotswood H, Tsai L, Malhotra A. Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia. N Engl J Med. 2021 Apr 22;384(16):1503-1516. doi: 10.1056/NEJMoa2028700. Epub 2021 Feb 25.

name: From Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York — both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) — all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.);...

family: Rosas

full_name: Ivan O. Rosas

given: Ivan O.

family: Bräu

full_name: Norbert Bräu

given: Norbert

family: Waters

full_name: Michael Waters

given: Michael

family: Go

full_name: Ronaldo C. Go

given: Ronaldo C.

family: Hunter

full_name: Bradley D. Hunter

given: Bradley D.

family: Bhagani

full_name: Sanjay Bhagani

given: Sanjay

family: Skiest

full_name: Daniel Skiest

given: Daniel

family: Aziz

full_name: Mariam S. Aziz

given: Mariam S.

family: Cooper

full_name: Nichola Cooper

given: Nichola

family: Douglas

full_name: Ivor S. Douglas

given: Ivor S.

family: Savic

full_name: Sinisa Savic

given: Sinisa

family: Youngstein

full_name: Taryn Youngstein

given: Taryn

family: Del Sorbo

full_name: Lorenzo Del Sorbo

given: Lorenzo

family: Cubillo Gracian

full_name: Antonio Cubillo Gracian

given: Antonio

family: De La Zerda

full_name: David J. De La Zerda

given: David J.

family: Ustianowski

full_name: Andrew Ustianowski

given: Andrew

family: Bao

full_name: Min Bao

given: Min

family: Dimonaco

full_name: Sophie Dimonaco

given: Sophie

family: Graham

full_name: Emily Graham

given: Emily

family: Matharu

full_name: Balpreet Matharu

given: Balpreet

family: Spotswood

full_name: Helen Spotswood

given: Helen

family: Tsai

full_name: Larry Tsai

given: Larry

family: Malhotra

full_name: Atul Malhotra

given: Atul

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the clinical study data request platform https://vivli.org.

Further details on Roche's criteria for eligible studies are available here: https://vivli.org.

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

location_country:
Italy
Netherlands
Germany
France
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: University of Miami Miller School of Medicine

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria

location_facility: Robert Wood Johnson University Hospital/Rutgers

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: James J Peters Veterans Administration Medical Center - NAVREF

location_facility: Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

summary: This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.


title: A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

summary: The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Greece
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Thailand
Argentina
Korea, Republic of
Switzerland
Netherlands
Hungary
Germany
United States
Italy
Austria
Brazil
Serbia
Mexico
Spain
Turkey

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete; Tudogyogyaszati Ambulancia

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hospital Regional Universitario de Malaga

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Kantonsspital St.Gallen Medizin Onkologie; Klinik fuer Onkologie und Haematologie

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Chonnam National University Hwasun Hospital

location_facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

location_facility: Taipei Medical University -Shuang Ho Hospital

location_facility: Uzhgorod Nat. University Central Municip Hosp; Onc Center

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Institute for pulmonary diseases of Vojvodina

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Inonu University Medical Faculty of Medicine; Medical Oncology Department

location_facility: US oncology research at Minnesota Oncology

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)

location_facility: St. Petersburg Clinical Scientific Center of special services medical assis (oncology)

location_facility: Hospital General Universitario de Alicante

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Taichung Veterans General Hospital; Dept of Internal Medicine

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: National Taiwan University Hospital; Oncology

location_facility: Austin Hospital Olivia Newton John Cancer Centre

location_facility: Centre Georges Francois Leclerc; Recherche Clinique

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: CEMER Centro Medico de Enfermedades Respiratorias

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Virginia Cancer Specialists (Fairfax) - USOR

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Klinik Schillerhöhe; Pneumologische Onkologie


title: A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

acronym: ADHERE

summary: This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

ipd_sharing: Undecided

lead_sponsor: argenx

location_country:
Romania
Belgium
Russian Federation
Denmark
Ukraine
France
Japan
Poland
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Georgia
Spain
Latvia

location_facility:
Investigator site 136
Investigator site 1
Investigator site 8
Investigator site 92
Investigator site 76
Investigator site 117
Investigator site 74
Investigator site 105
Investigator site 70
Investigator site 128
Investigator site 122
Investigator site 119
Investigator site 9
Investigator site 54
Investigator site 32
Investigator site 106
Investigator site 10
Investigator site 88
Investigator site 30
Investigator site 60
Investigator site 118
Investigator site 93
Investigator site 19
Investigator site 25
Investigator site 26
Investigator site 126
Investigator site 115
Investigator site 62
Investigator site 27
Investigator site 127
Investigator site 67
Investigator site 89
Investigator Site 3
Investigator site 90
Investigator site 91
Investigator site 103
Investigator site 55
Investigator site 112
Investigator site 38
Investigator site 99
Investigator site 116
Investigator site 14
Investigator site 2
Investigator site 11
Investigator site 66
Investigator Site 7
Investigator site 135
Investigator site 113
Investigator site 100
Investigator site 17
Investigator site 125
Investigator site 16
Investigator site 87
Investigator site 51
Investigator site 28
Investigator site 31
Investigator site 120
Investigator site 43
Investigator site 82
Investigator site 85
Investigator site 130
Investigator site 114
Investigator site 58
Investigator site 124
Investigator site 97
Investigation site 121
Investigator site 69
Investigator site 94
Investigator site 15
Investigator site 132
Investigator site 134
Investigator site 72
Investigator site 42
Investigator site 56
Investigator site 131
Investigator site 63
Investigator site 84
Investigator site 47
Investigator site 50
Investigator site 20
Investigator site 22
Investigator site 64
Investigator site 78
Investigator site 95
Investigator site 68
Investigator site 109
Investigator site 53
Investigator site 41
Investigator site 35
Investigator site 29
Investigator site 40
Investigator site 46
Investigator site 133
Investigator site 39
Investigator site 96
Investigator site 98
Investigator site 86
Investigator site 49
Investigator site 107
Investigator site 13
Investigator Site 5
Investigator site 57
Investigator site 101
Investigator site 77
Investigator site 52
Investigator site 61
Investigator site 21
Investigator site 59
Investigator site 81
Investigator site 110
Investigator site 73
Investigator Site 4
Investigator site 79
Investigator site 123
Investigator site 71
Investigator site 83
Investigator site 129
Investigator site 111
Investigator site 12
Investigator site 44
Investigator Site 6
Investigator site 104
Investigator site 33
Investigator site 34
Investigator site 65
Investigator site 24
Investigator site 75
Investigator site 45
Investigator site 108
Investigator site 48
Investigator site 102
Investigator site 80
Investigator site 18
Investigator site 37
Investigator site 23

intervention_type: Other


title: Development and Validation of a Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

acronym: DYNAKT

summary:
The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up.

As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Raynaud M, Aubert O, Divard G, Reese PP, Kamar N, Yoo D, Chin CS, Bailly É, Buchler M, Ladrière M, Le Quintrec M, Delahousse M, Juric I, Basic-Jukic N, Crespo M, Silva HT Jr, Linhares K, Ribeiro de Castro MC, Soler Pujol G, Empana JP, Ulloa C, Akalin E, Böhmig G, Huang E, Stegall MD, Bentall AJ, Montgomery RA, Jordan SC, Oberbauer R, Segev DL, Friedewald JJ, Jouven X, Legendre C, Lefaucheur C, Loupy A. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit Health. 2021 Oct 27. pii: S2589-7500(21)00209-0. doi: 10.1016/S2589-7500(21)00209-0. [Epub ahead of print]

family: Raynaud

full_name: Marc Raynaud

given: Marc

family: Aubert

full_name: Olivier Aubert

given: Olivier

family: Divard

full_name: Gillian Divard

given: Gillian

family: Reese

full_name: Peter P Reese

given: Peter P

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Yoo

full_name: Daniel Yoo

given: Daniel

family: Chin

full_name: Chen-Shan Chin

given: Chen-Shan

family: Bailly

full_name: Élodie Bailly

given: Élodie

family: Buchler

full_name: Matthias Buchler

given: Matthias

family: Ladrière

full_name: Marc Ladrière

family: Le Quintrec

full_name: Moglie Le Quintrec

given: Moglie

family: Delahousse

full_name: Michel Delahousse

given: Michel

family: Juric

full_name: Ivana Juric

given: Ivana

family: Basic-Jukic

full_name: Nikolina Basic-Jukic

given: Nikolina

family: Crespo

full_name: Marta Crespo

given: Marta

family: Silva

full_name: Helio Tedesco Silva

given: Helio Tedesco

suffix: Jr

family: Linhares

full_name: Kamilla Linhares

given: Kamilla

family: Ribeiro de Castro

full_name: Maria Cristina Ribeiro de Castro

given: Maria Cristina

family: Soler Pujol

full_name: Gervasio Soler Pujol

given: Gervasio

family: Empana

full_name: Jean-Philippe Empana

given: Jean-Philippe

family: Ulloa

full_name: Camilo Ulloa

given: Camilo

family: Akalin

full_name: Enver Akalin

given: Enver

family: Böhmig

full_name: Georg Böhmig

given: Georg

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
Brazil
Chile
Croatia
France
Argentina
Spain
United States

location_facility: Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

location_facility: Bretonneau Hospital, Nephrology and Immunology Department

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Renal Transplantation Service

location_facility: Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center

location_facility: Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy

location_facility: Universidade Federal de São Paulo, Hospital do Rim, Escola Paulista de Medicina

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

location_facility: Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb

location_facility: Unidad de Trasplante Renopáncreas, Centro de Educación Médica e Investigaciones Clínicas

location_facility: Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

location_facility: Division of Transplantation, Department of Surgery, Feinberg School of Medicine, Northwestern University

location_facility: Department of Nephrology, Hospital del Mar

location_facility: Department of Surgery, Johns Hopkins University School of Medicine

location_facility: Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program

location_facility: William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

acronym: BE HEARD I

summary: The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Greece
Israel
Norway
Belgium
Australia
Spain
Turkey
Denmark
Canada


location_country:
Italy
United States
Chile
South Africa
Switzerland
France
Japan
Poland
Australia
Russian Federation
New Zealand
Spain
Canada
United Kingdom
Colombia

acronym: DOR/ISL Open-Label Switch

location_facility: Melbourne Sexual Health Centre ( Site 2305)

location_facility: Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)

location_facility: Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 2401)

location_facility: Saint Hope Foundation, Inc. ( Site 1037)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)

location_facility: Midway Immunology and Research ( Site 1030)

location_facility: EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)

location_facility: Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)

location_facility: Georgetown University Hospital ( Site 1018)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 2403)

location_facility: Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)

location_facility: Hospital Universitario Infanta Leonor ( Site 1601)

location_facility: Brighton and Sussex University Hospital NHS Trust ( Site 1908)

location_facility: SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)

location_facility: Centro de Investigacion Clinica UC CICUC ( Site 1303)

location_facility: Tokyo Medical University Hospital ( Site 2404)

location_facility: Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)

location_facility: Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)

location_facility: Holdsworth House Medical Practice ( Site 2300)

location_facility: Kansas City CARE Health Center ( Site 1008)

location_facility: University of North Carolina at Chapel Hill ( Site 1042)

location_facility: Infectious Clinical Hospital #2 ( Site 1719)

location_facility: Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)

location_facility: Southern Alberta HIV Clinic ( Site 1108)

location_facility: Toronto General Hospital - University Health Network ( Site 1105)

location_facility: FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)

location_facility: Hospital Universitario La Paz ( Site 1604)

location_facility: Inselspital Universitaetsspital Bern ( Site 3303)

location_facility: Chatham County Health Department ( Site 1043)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 2014)

location_facility: The Crofoot Research Center, Inc. ( Site 1005)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)

location_facility: National Hospital Organization Osaka National Hospital ( Site 2402)

location_facility: North Texas ID Consultants, PA ( Site 1003)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)

location_facility: Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)

location_facility: Universitaetsspital Zuerich ( Site 3300)

location_facility: Triple O Research Institute, P.A. ( Site 1026)

location_facility: Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)

location_facility: North Manchester General Hospital ( Site 1902)

location_facility: Vancouver ID Research and Care Centre Society ( Site 1100)

location_facility: Hopitaux Universitaires de Geneve HUG. ( Site 3304)

location_facility: Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 2015)

location_facility: Ospedale Regionale di Lugano Civico ( Site 3305)

location_facility: Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2406)

location_facility: Hospital Clinic i Provincial ( Site 1600)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 1907)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 1305)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1606)

location_facility: Texas Centers for Infectious Disease Associates P.A. ( Site 1022)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1603)

location_facility: CHU de Toulouse - Hopital Purpan ( Site 2004)

location_facility: Hopital Francois Mitterrand ( Site 2019)

title: A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy

summary: This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.


ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
United Kingdom
France
Czechia
Japan
Hungary
Belgium
Spain
Canada
Latvia

acronym: PACIFIC-AF

location_facility: Hôpital Cantonal Universitaire de Genève

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

location_facility: Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz

location_facility: Albert Schweitzer Ziekenhuis, Locatie Dordwijk

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: P. Stradins Clinical University Hospital

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

location_facility: University of Semmelweis/ Semmelweis Egyetem

location_facility: Institut universitaire de cardiologie et de pneumologie

location_facility: Centre Hospitalier Régional - Saint Brieuc

title: Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation

summary:
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.

status_simplified: Completed


design_allocation: Non-Randomized

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Peru
Guatemala
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Oman
Taiwan
India
Croatia
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
Hungary
Germany
United States
Italy
Austria
Brazil
Lebanon
Mexico
Czechia
Israel
Tunisia
Spain
Estonia

title: A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301

summary:
The purpose of this extension study is to establish efficacy and safety of ligelizumab. This will be assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed.

This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301


ipd_sharing_description: All individual patient data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
United States
France
Japan
Australia
Germany

acronym: LIBERTY-BP

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

summary:
The primary objective of the study is to demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP).

The secondary objectives of the study are:

To evaluate the OCS-sparing effects of dupilumab in patients with BP
To evaluate the effect of dupilumab on itch in patients with BP
To evaluate the effects of dupilumab on health-related quality of life measures in patients with BP
To evaluate the effect of dupilumab in circulating BP180 and BP230 autoantibody titers
To assess the safety and tolerability of dupilumab administered to patients with BP
To characterize the trough concentrations of functional dupilumab over time following administration of dupilumab in patients with BP
To assess the immunogenicity of dupilumab in patients with BP over time


title: An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma With Carfilzomib, Pomalidomide, and Dexamethasone (KPd)

acronym: SELECT

summary: A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Italy
Germany
France
Greece
Spain
Estonia
Denmark
United States

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Rocky Mountain Cancer Centers Denver Midtown

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: University General Hospital of Evros-Alexandroupolis District

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: United States Oncology Regulatory Affairs Corporate Office

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: US Oncology Research Investigational Products Center

location_facility: Baylor Charles A Sammons Cancer Center at Dallas


location_country:
Italy
Austria
Netherlands
Germany
France
Czechia
Bulgaria
Japan
Georgia
Poland
Hungary
Belgium
Russian Federation
Spain
Turkey
United States
United Kingdom
Ukraine

acronym: ADVANCE

location_facility:
Investigator Site 0480030
Investigator Site 0390021
Investigator Site 0330018
Investigator Site 0900008
Investigator Site 0010042
Investigator Site 0900007
Investigator Site 3590002
Investigator Site 0390020
Investigator Site 0310005
Investigator Site 0900017
Investigator Site 0340015
Investigator Site 0480010
Investigator Site 0010046
Investigator Site 0340004
Investigator Site 0010034
Investigator site 0310006
Investigator Site 0480013
Investigator Site 0340009
Investigator Site 0900005
Investigator Site 0010045
Investigator site 0070006
Investigator Site 0900010
Investigator Site 9950011
Investigator site 0480026
Investigator Site 0480008
Investigator Site 0390010
Investigator Site 0810025
Investigator Site 0010049
Investigator Site 3800022
Investigator Site 0010041
Investigator Site 0430002
Investigator Site 0810023
Investigator Site 0490012
Investigator Site 0310007
Investigator Site 9950009
Investigator site 3800006
Investigator Site 0440008
Investigator Site 0390016
Investigator site 0070010
Investigator Site 0320014
Investigator Site 0330009
Investigator site 0360010
Investigator Site 0070015
Investigator Site 0480012
Investigator Site 0320011
Investigator Site 0490010
Investigator Site 0340014
Investigator site 0810016
Investigator Site 0480011
Investigator Site 0390019
Investigator Site 0900019
Investigator site 0810018
Investigator Site 0390012
Investigator Site 0440012
Investigator Site 0810010
Investigator Site 9950007
Investigator Site 0340007
Investigator Site 0810021
Investigator Site 0430004
Investigator Site 0810015
Investigator Site 0360015
Investigator Site 0900016
Investigator Site 0390014
Investigator Site 0340030
Investigator Site 0330008
Investigator Site 0330016
Investigator site 0010037
Investigator Site 0340011
Investigator Site 4200001
Investigator site 0810014
Investigator Site 0390015
Investigator Site 0440014
Investigator Site 0330015
Investigator Site 0330017
Investigator Site 0360006
Investigator site 0810017
Investigator Site 4200008
Investigator Site 0900002
Investigator Site 0900004
Investigator Site 0900013
Investigator Site 0320012
Investigator Site 4200006
Investigator Site 0900018
Investigator Site 0390011
Investigator Site 0070013
Investigator Site 0810024
Investigator Site 0900006
Investigator Site 9950006
Investigator Site 0900009
Investigator Site 0900015
Investigator Site 0330019
Investigator Site 0440010
Investigator Site 0390017
Investigator Site 0010038
Investigator Site 3590001
Investigator Site 0390009
Investigator Site 0810022
Investigator Site 0480016
Investigator site 0810020
Investigator Site 0430003
Investigator Site 0390018
Investigator site 0810011
Investigator Site 0010040
Investigator Site 0340006
Investigator Site 9950012
Investigator Site 0480014
Investigator Site 0900014
Investigator Site 0320020
Investigator Site 0360014
Investigator site 0340012
Investigator Site 4200007
Investigator Site 0340013
Investigator Site 0320015
Investigator Site 0070007
Investigator Site 0070012
Investigator Site 0490008
Investigator Site 0900003
Investigator site 0320002
Investigator Site 0480015
Investigator Site 9950008
Investigator Site 0360004

title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP)

summary: This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in patients with primary ITP.


intervention_type: Biological

status: Withdrawn

ipd_sharing_description:
CSL will consider requests to share Individual Patient Data (IPD) from systemic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

lead_sponsor: CSL Behring

location_country:
Italy
United States
Switzerland
Mexico
Germany
France
Poland
Belgium
Argentina
Australia
Spain
Canada
United Kingdom

location_facility: Centro De Estudios De Investigation Basica Y Clinica S.C

location_facility: Internal Medicine, Nantes University Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: University of Pennsylvania - Perelman Center

location_facility: Universita degli Studi di Napoli Federico II

location_facility: The University Of Texas Medical School At Houston (Utms)

location_facility: University Clinical Centre, Medical University of Gdansk

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: Centro de Investigacion y Tratamiento Reumatologico S.C.

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Hospital Universitari Materno Infantil Vall Dhebron

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: APRILLUS Asistencia e Investigacion Clinica

location_facility: Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

location_facility: Uniwersytecki Szpital Kliniczny W Bialymstoku

location_facility: John Hunter Hospital / Autoimmune Resource and Research Centre

location_facility: Louisiana State University Health Sciences Center

location_facility: Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie

location_facility: Centro de Alta Especialidad en Reumatologia

location_facility: Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP)

location_facility: Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie

location_facility: Royal Free Hospital-Royal Free London NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie

location_facility: Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Klinika Dermatologii Szpital im. Dzieciątka Jezus

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Universita Degli Studi Di Bari Aldo Moro

location_facility: Sanatorio Parque S.A y Consultorios Externos Asociados

location_facility: Universitaetsmedizin der Johannes Gutenberg

location_facility: Lombardi Cancer Center-Georgetown University

title: A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis

summary:
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.

Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

status_simplified: Unknown


ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Romania
Belgium
Australia
Russian Federation
Ukraine
India
Thailand
France
Japan
Poland
Slovakia
Colombia
South Africa
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Serbia
Mexico
Spain
Turkey

acronym: Tuscany 2

location_facility: Grant Medical Foundation, Ruby Hall Clinic

location_facility: Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija

location_facility: Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"

location_facility: The University of Chicago Medical Center

location_facility: Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez

location_facility: Medical center of Limited Liability Company "Health Clinic", medical clinical research center

location_facility: Medical Research Center Of Connecticut, LLC

location_facility: The University of Chicago Medical Center (clinic address)

location_facility: Chest X-ray Facility - BMI Bishops Wood Hospital

location_facility: National Hospital Organization Sendai Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Studiengesellschaft BSF UG (haftungsbeschränkt)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: IRCCS "Saverio de Bellis", UOC Gastroenterologia

location_facility: MeDiNova North London Quality Research Site

location_facility: Gastroenterology Associates of Northern VA

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

location_facility: Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: Bulent Ecevit Universitesi Tip Fakultesi

location_facility: University Hospitals Leuven/Department of Gastroenterology

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center

location_facility: Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Research Institute of Antimicrobial Chemotherapy

location_facility: Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"

location_facility: MeDiNova Northamptonshire Quality Research Site

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion

location_facility: Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"

location_facility: Clinical Hospital named after S.R. Mirotvortsev

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: Allegiance Internal Medicine and Allegiance Research Specialists

location_facility: UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"

location_facility: Medical Centre Medical Clinic Blagomed LLC

location_facility: Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC

location_facility: Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"

location_facility: "ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD

location_facility: Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent

location_facility: M.S. Ramaiah Medical College and Hospitals

location_facility: Endoscopy Facility - Spire Little Aston Hospital

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"

location_facility: Perm Clinical Centre of the Federal Medical-Biological Agency

location_facility: Clinexpert Tatabanya, Szent Borbala Hospital

location_facility: King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

location_facility: Limited Liability Company "Medicinsky Center SibNovoMed"

location_facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

location_facility: Tokyo Medical And Dental University Hospital

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: Gastroenterology Associates, PA of Greenville

location_facility: Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

location_facility: A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Gastroenterology Consultants of San Antonio, PA

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Endoscopy Facility - Orpington Endoscopy Centre

title: A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

summary: This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.


title: An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer

summary: The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B and C), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B and C), to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D).

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
United States
Spain
France
Japan
Puerto Rico
China
Germany
Korea, Republic of
Taiwan

location_facility: First Affiliated Hospital, Xi'an Jiaotong University

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The First Bethune Hospital of Jilin University

location_facility: The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kobe City Medical Center General Hospital

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: The Fifth Affiliated Hospital of Guangzhou Medical University

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Kliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

location_facility: USC - Norris Comprehensive Cancer Center

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Shengjing Hospital of China Medical University

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Oncologic Hospital, Puerto Rico Medical Center

location_facility: West China School of Medicine/West China Hospital, Sichuan University


title: Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

ipd_sharing: No

lead_sponsor: Incyte Corporation

location_country:
Italy
United States
Netherlands
France
Bulgaria
Poland
Spain
Germany
Canada

location_facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Diagnostic Consultative Center II Sofia EOOD

location_facility: IDEI (Instituto de Dermatología Integral).

location_facility: University Hospital " Prof. Dr Stoyan Kirkovich"

location_facility: University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz)

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Diagnostic Consultative Center Ii Sofia Eood

location_facility: Synexus Polska Sp. Z O.O. Oddzial Warszawie

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Center For Dermatology Cosmetic and Laser Surgery

location_facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie

location_facility: UCI Health Beckman Laser Institute and Medical Center

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Hospital La Paz (Hospital Universitario La Paz )

location_facility: University Hospital Prof Dr Stoyan Kirkovich

location_facility: Synexus Affiliate - Krakowskie Centrum Medyczne

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR

location_facility: Synexus Polska Sp. Z o.o. Oddział w Częstochowie

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Uci Beckman Laser Institute and Medical Clinic


title: A Multicenter, Noninterventional, Prospective Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Moderate to Severe Plaque Psoriasis in Daily Practice

acronym: CIMREAL

summary: The purpose of the study is to assess the effectiveness of certolizumab pegol in patients with moderate to severe plaque psoriasis as part of routine clinical practice.

ipd_sharing_description: Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.

location_country:
Italy
France
Czechia
Greece
Belgium
Spain
Germany
United Kingdom
Canada


title: Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

summary: to evaluate the feasibility, safety and performance of the HighLife 28mm Transcatheter Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

lead_sponsor: HighLife SAS

location_country:
France
Poland
Belgium
Australia
Germany
United Kingdom

location_facility: Heart Center, University Hospital Dresden

location_facility: University Heart Center Freiburg - Bad Krozingen

location_facility: University Hospital of Lord's Transfiguration

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital

intervention_type: Device


title: A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer

summary: The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Netherlands
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Fundacao Antonio Prudente-Hospital Ac Camargo

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: PERSONAL Oncologia de Precisao e Personalizada

location_facility: Hospital Civil De Guadalajara Juan I Menchaca

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Oddzial Kliniczny Chirurgii Klatki Piersiowej

location_facility: University Hospitals Cleveland Medical Center

location_facility: The University of Texas MD Anderson Cancer Center-merge

location_facility: Kliniken Der Stadt Koeln Ggmbh Krankenhaus Mehrheim

location_facility: Real E Benemerita Associacao Portuguesa De Beneficencia

location_facility: Hematology-Oncology Associates Of Fredricksburg, Inc


ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Italy
Brazil
Switzerland
France
Israel
Australia
Russian Federation
Spain
Turkey

acronym: CULMINATE

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Division of Hematology, Cardarelli Hospital

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Ankara University Medical Faculty Hematology Department - Hematology

location_facility: St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Hospital Estadual de Campinas - Centro de Hematologia e Hemoterapia

title: A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

summary: The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.


title: A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia

acronym: SAPPHIRE

summary: The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Italy
South Africa
Mexico
France
Czechia
Poland
Israel
Slovakia
Romania
Hungary
Spain
United States


title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

acronym: MELODY

summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

family: Ginsburg

full_name: Amy Sarah Ginsburg

given: Amy Sarah

family: Srikantiah

full_name: Padmini Srikantiah

given: Padmini

title: Respiratory syncytial virus: promising progress against a leading cause of pneumonia

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: MedImmune LLC

location_country:
Finland
Australia
Belgium
Russian Federation
France
Japan
Lithuania
Panama
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain
Estonia
Latvia


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

summary: The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

ReferenceCitation: Bril V, Benatar M, Andersen H, Vissing J, Brock M, Greve B, Kiessling P, Woltering F, Griffin L, Van den Bergh P; MG0002 Investigators. Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis: A Phase 2 Randomized Control Trial. Neurology. 2021 Feb 9;96(6):e853-e865. doi: 10.1212/WNL.0000000000011108. Epub 2020 Nov 20.

family: Bril

full_name: Vera Bril

given: Vera

family: Benatar

full_name: Michael Benatar

given: Michael

family: Andersen

full_name: Henning Andersen

given: Henning

family: Vissing

full_name: John Vissing

given: John

family: Brock

full_name: Melissa Brock

given: Melissa

family: Greve

full_name: Bernhard Greve

given: Bernhard

family: Kiessling

full_name: Peter Kiessling

given: Peter

family: Woltering

full_name: Franz Woltering

given: Franz

family: Griffin

full_name: Laura Griffin

given: Laura

family: Van den Bergh

full_name: Peter Van den Bergh

journal_name: Neurology

oa_colors: green hybrid

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Ghent University - Ghent University Academic Bibliography

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Efficacy and safety of rozanolixizumab in moderate-to-severe generalised myasthenia gravis

location_country:
Italy
United States
Serbia
Germany
France
Czechia
Japan
Poland
Georgia
Hungary
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom
Taiwan


title: An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)

acronym: INTREPID OLE

summary: The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab.

status: Enrolling by invitation

location_country:
Austria
South Africa
India
Germany
France
Czechia
Korea, Republic of
Israel
Poland
Slovakia
Hungary
Russian Federation
Spain
United States
United Kingdom
Canada
Taiwan
Ukraine


title: A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

summary: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

location_country:
Italy
Chile
India
Hong Kong
France
Bulgaria
Japan
Poland
Thailand
Argentina
Russian Federation
China
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan