title: A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.

acronym: AcceleRET-MTC

summary: A study to evaluate the efficacy and safety of pralsetinib compared with SOC treatment (cabozantinib or vandetanib) for participants with RET (rearranged during transfection)-mutant MTC who have not previously received a SOC MultiKinase Inhibitor (MKI) therapy. Participants will be randomized in a 1:1 ratio into one of two treatment arms: Arm A (pralsetinib) or Arm B (investigator's choice of either cabozantinib or vandetanib). Participants whose disease progresses during SOC treatment will be offered the option to cross over to receive pralsetinib after confirmation of progressive disease by blinded independent central review (BICR).

study_start_date_type: Anticipated

status: Not yet recruiting

location_country:
Greece
Romania
Australia
Denmark
Ukraine
India
Croatia
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Netherlands
Philippines
Bulgaria
Hungary
Portugal
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Krakowie - Apteka/Pharmacy; Pharmacy

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Hospital Regional Universitario de Malaga

location_facility: Institutul National de Endocrinologie "C. I. Parhon"; Sectorul 1 BUCUREȘTI

location_facility: Prof Dr I Chiricuta Institute of Oncology; Oncology Department

location_facility: Centre Hospitalier Universitaire de Sherbrooke; Pharmacie de Chimiotherapie

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: Semmelweis Egyetem, II. Belgyógyászati Klinika

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

location_facility: Ukr. Scientific Practical Center of Endocrine Surgery,Transplantation of Endocrine organs&Tissues

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Institut Universitaire de Cancer de Toulouse Oncopole; IUCT- Oncopole

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

location_facility: McGill University Health Center; Glen-Cedars Cancer Centre, Oncology Pharmacy

location_facility: Medizinische Universität Graz; Klinische Abteilung für Allgemeine HNO

location_facility: Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima

location_facility: Clinica Universidad Navarra; Servicio de Farmacia

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Sparsh Hospitals & Critical Care (P) Ltd.

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Clinical Hospital Centre Osijek; Hematology

location_facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

location_facility: The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

location_facility: Centre Hospitalier Universitaire Lyon; Institut Hématologique et d'Oncologie Pédiatrique

location_facility: Siriraj Hospital, Mahidol Uni ; Division of Rheumatology, Dept. of Medicine

location_facility: Hospital Universitario HM Sanchinarro - CIOCC; Farmacia - Ensayos Clínicos

location_facility: Complex Oncology Center Plovdiv; Department of Medical Oncology and Oncology Diseases in Pneumology

location_facility: The Alfred Hospital;Clinical Trial Pharmacy

location_facility: Chulalongkorn University Hospital; Hematology

location_facility: Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology

location_facility: Tom Baker Cancer Centre; Dept of Pathology

location_facility: Hôtel Dieu -Angers; Pharmacie / Secteur Essais Cliniques

location_facility: SI Institute for general and urgent surgery n.a. V.T.Zaitseva of NAMS of Ukraine

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: University of Athens Medical School - Regional General Hospital Alexandra

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Fundação Pio XII Hospital de Câncer de Barretos

location_facility: MD Anderson Cancer Center Madrid - España; Servicio de Farmacia

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Saint Louis University Hospital of Sacred Heart

location_facility: Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

location_facility: Centrum Onkologii-Instytut Im. Marii Skłodowskiej Curie; I Klinika Radioterapii i Chemioterapii


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Guatemala
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Ireland
China
United States
Germany
United Kingdom
Italy
Israel
Spain
Turkey

location_facility: Royal Brisbane and Women s Hospital ( Site 2304)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)

location_facility: Washington University School of Medicine ( Site 0027)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1501)

location_facility: National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)

location_facility: Princess Margaret Hospital. ( Site 2502)

location_facility: Kansai Medical University Hospital ( Site 2622)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 2414)

location_facility: Hallym University Sacred Heart Hospital ( Site 2806)

location_facility: Seoul National University Hospital ( Site 2803)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)

location_facility: Hollywood Private Hospital-Medical Oncology ( Site 2308)

location_facility: China Medical University Hospital ( Site 2903)

location_facility: The Christie NHS Foundation Trust ( Site 2209)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0403)

location_facility: First Hospital of Lanzhou University ( Site 2417)

location_facility: Hamilton Health Sciences - Juravinski Site ( Site 0106)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2618)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)

location_facility: Klinikum Rechts der Isar der TU Muenchen ( Site 1200)

location_facility: The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment

location_facility: Centre Hospitalier Annecy Genevois ( Site 1117)

location_facility: Oncologos del Occidente S.A. ( Site 0525)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 2902)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 1603)

location_facility: National Cancer Center Hospital East ( Site 2601)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 2007)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 0705)

location_facility: Aichi Cancer Center Hospital ( Site 2603)

location_facility: Institut du Cancer Avignon-Provence ( Site 1103)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)

location_facility: James Graham Brown Cancer Center ( Site 0017)

location_facility: LinYi Cancer Hospital-Gastrology department ( Site 2463)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2610)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)

location_facility: Seoul National University Bundang Hospital ( Site 2804)

location_facility: Universitaetsklinikum Leipzig ( Site 1211)

location_facility: Charite Berlin Campus Virchow-Klinikum ( Site 1202)

location_facility: Kobe City Medical Center General Hospital ( Site 2606)

location_facility: Clinica Universidad Catolica del Maule ( Site 0411)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)

location_facility: Osaka International Cancer Institute ( Site 2607)

location_facility: Nanjing Drum Tower Hospital ( Site 2419)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0101)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)

location_facility: Hospital Privado de Cordoba ( Site 0204)

location_facility: Centre Georges Francois Leclerc ( Site 1106)

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)

location_facility: Hillel Yaffe Medical Center ( Site 1503)

location_facility: Georgetown University Medical Center ( Site 0009)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 0504)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 2447)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2609)

location_facility: Soluciones Gastrointestinales S.A. ( Site 0706)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1902)

location_facility: National Taiwan University Hospital ( Site 2901)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1801)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0414)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2605)

location_facility: National Cheng Kung University Hospital ( Site 2904)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)

location_facility: Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)

location_facility: Leningrad Regional Oncology Center ( Site 1810)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1907)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2000)

location_facility: Humanitas Research Hospital ( Site 1600)

location_facility: Korea University Guro Hospital ( Site 2808)

location_facility: AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)

location_facility: CHU UCL Namur Site de Godinne ( Site 1005)

location_facility: Hospital Universitario General de Asturias ( Site 1901)

location_facility: Hospital General Gregorio Maranon de Madrid ( Site 1904)

location_facility: National Cancer Center Hospital ( Site 2602)

location_facility: Severance Hospital Yonsei University Health System ( Site 2800)

location_facility: UMASS Memorial Medical Center ( Site 0020)

location_facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2612)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

type: Other Identifier

type: Registry Identifier

source: euctr

title: Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)

summary:
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.

The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both 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), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

acronym: PROVENT

summary: This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

status: Active, not recruiting

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

name: From the H. Lee Moffitt Cancer Center and Research Institute, Tampa (S.J.A., A.C., J.E.G.), Cancer Specialists of North Florida, Jacksonville (A.V.), Florida Cancer Specialists, Fleming Island (A.V.), and Florida Hospital Cancer Institute, Orlando (T.M.) — all in Florida; Tennessee Oncology, Chattanooga (D.D.), and Sarah Cannon Research Institute, Nashville (D.D., D.R.S.) — both in Tennessee; Hospital Universitario Virgen Macarena, Seville (D.V.), and Hospital Universitario 12 de Octubre, CiberOnc,...

family: Antonia

full_name: Scott J. Antonia

given: Scott J.

sequence: first

family: Villegas

full_name: Augusto Villegas

given: Augusto

sequence: additional

family: Daniel

full_name: Davey Daniel

given: Davey

family: Vicente

full_name: David Vicente

given: David

family: Murakami

full_name: Shuji Murakami

given: Shuji

family: Hui

full_name: Rina Hui

given: Rina

family: Kurata

full_name: Takayasu Kurata

given: Takayasu

family: Chiappori

full_name: Alberto Chiappori

given: Alberto

family: Lee

full_name: Ki H. Lee

given: Ki H.

family: de Wit

full_name: Maike de Wit

given: Maike

family: Cho

full_name: Byoung C. Cho

given: Byoung C.

family: Bourhaba

full_name: Maryam Bourhaba

given: Maryam

family: Quantin

full_name: Xavier Quantin

given: Xavier

family: Tokito

full_name: Takaaki Tokito

given: Takaaki

family: Mekhail

full_name: Tarek Mekhail

given: Tarek

family: Planchard

full_name: David Planchard

family: Kim

full_name: Young-Chul Kim

given: Young-Chul

family: Karapetis

full_name: Christos S. Karapetis

given: Christos S.

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

family: Ostoros

full_name: Gyula Ostoros

given: Gyula

family: Kubota

full_name: Kaoru Kubota

given: Kaoru

family: Gray

full_name: Jhanelle E. Gray

given: Jhanelle E.

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html. Published 2020. Accessed 01 July 2020.

ReferenceCitation: Domachowske JB, Khan AA, Esser MT, Jensen K, Takas T, Villafana T, Dubovsky F, Griffin MP. Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J. 2018 Sep;37(9):886-892. doi: 10.1097/INF.0000000000001916.

ReferenceCitation: Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl Met al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020;79(1):39-52. Furie RA, Morand EF, Bruce IN, Manzi S, Kalunian KC, Vital EM et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. The Lancet Rheumatology. 2019;1(4):e208-e19.

ReferenceCitation: Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

ReferenceCitation: Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3). pii: e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.

ReferenceCitation: Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simões EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556. Erratum in: N Engl J Med. 2020 Aug 13;383(7):698.

name: From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo...

ReferenceCitation: Lamb EJ, Levey AS, Stevens PE. The Kidney Disease Improving Global Outcomes (KDIGO) guideline update for chronic kidney disease: evolution not revolution. Clin Chem. 2013 Mar;59(3):462-5. doi: 10.1373/clinchem.2012.184259.

ReferenceCitation: Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. Epub 2016 Aug 25. Review.

ReferenceCitation: Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4(2):213-26. Morand EF, Furie RA. Anifrolumab in Systemic Lupus Erythematosus. Reply. N Engl J Med. 2020;382(17):1666.

ReferenceCitation: Poland GA, Ovsyannikova IG, Kennedy RB. Personalized vaccinology: A review. Vaccine. 2018 Aug 28;36(36):5350-5357. doi: 10.1016/j.vaccine.2017.07.062. Epub 2017 Jul 31. Review.

ReferenceCitation: Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.

ReferenceCitation: Wagner A, Weinberger B. Vaccines to Prevent Infectious Diseases in the Older Population: Immunological Challenges and Future Perspectives. Front Immunol. 2020 Apr 23;11:717. doi: 10.3389/fimmu.2020.00717. eCollection 2020. Review.

ReferenceCitation: WHO. WHO Coronavirus Disease (COVID-19) Dashboard. 2020a.

ReferenceCitation: WHO. WHO R&D Blueprint COVID-19 Therapeutic Trial Synopsis Draft 18 February 2020. https://www.who.int/blueprint/priority-diseases/key-action/COVID19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Published 2020b. Accessed 25 September 2020.

ReferenceCitation: Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.

ReferenceCitation: Zimmermann P, Curtis N. Factors That Influence the Immune Response to Vaccination. Clin Microbiol Rev. 2019 Mar 13;32(2). pii: e00084-18. doi: 10.1128/CMR.00084-18. Print 2019 Mar 20. Review.

ReferenceCitation: Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6.

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

location_country:
France
Belgium
Spain
United States
United Kingdom


ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country: Italy Netherlands France Czechia Belgium Australia Spain

acronym: A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: Azienda Ospedaliero Universitaria Federico II Napoli

ipd_sharing: No

title: A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism

summary: This study will evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.


title: A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

acronym: TALON Ext

summary:
The purpose of this extension study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective is to assess brolucizumab's potential for long durability up to 20 weeks.

All eligible participants will be treated with brolucizumab regardless of their treatment in the TALON study.

The study period is 56 weeks including post-treatment follow-up.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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 https://www.clinicalstudydatarequest.com/

lead_sponsor: Novartis Pharmaceuticals

location_country:
Sweden
Switzerland
Netherlands
Spain
Germany
France
Czechia
Malaysia
Israel
Belgium
Australia
Portugal
United States
Korea, Republic of
Taiwan


location_country:
Italy
United States
Chile
Hong Kong
Mexico
Spain
Germany
France
Japan
Israel
Argentina
Australia
New Zealand
China
Puerto Rico
Russian Federation
Canada
Turkey
Korea, Republic of
Taiwan

location_facility: Clinical Trials of Texas, LLC ( Site 2614)

location_facility: Hospital Clinic de Barcelona ( Site 2102)

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)

location_facility: Hospital Universitari Vall d Hebron ( Site 2101)

location_facility: The Crofoot Research Center, Inc. ( Site 2611)

location_facility: Floridian Clinical Research, LLC ( Site 2656)

location_facility: Center targetnoy therapy-Gastroenterology ( Site 1918)

location_facility: Beijing YouAn Hospital, Capital Medical University ( Site 0605)

location_facility: Universitaetsklinikum Leipzig ( Site 0447)

location_facility: A O U Policlinico di Modena ( Site 1307)

location_facility: North Florida South Georgia Veterans Health System ( Site 2613)

location_facility: Genoma Research Group, Inc. ( Site 2669)

location_facility: Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)

location_facility: Gazi University Medical Faculty ( Site 2405)

location_facility: NYU Langone Health, New York ( Site 2627)

location_facility: General Hospital of Ningxia Medical University ( Site 0607)

location_facility: Hospital Universitario Virgen del Rocio ( Site 2105)

location_facility: Adobe Clinical Research, LLC ( Site 2644)

location_facility: Indago Research and Health Center Inc ( Site 2610)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0443)

location_facility: IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)

location_facility: Fundacion de Investigacion de Diego ( Site 3101)

location_facility: Medical Rehabilitation Center ( Site 1904)

location_facility: Russian University of People Friendship ( Site 1907)

location_facility: Yokohama City University Hospital ( Site 1411)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)

location_facility: Hospital Británico de Buenos Aires ( Site 0002)

location_facility: Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)

location_facility: University Health Network - Toronto General Hospital ( Site 0401)

location_facility: Centro de Investigacion y Gastroenterologia SC ( Site 1503)

location_facility: Fukui-ken Saiseikai Hospital ( Site 1410)

location_facility: Hope Clinical Research, Inc. ( Site 2601)

location_facility: Hospital Provincial del Centenario ( Site 0007)

location_facility: Centre Hospitalier et Universitaire Dupuytren ( Site 0810)

location_facility: Shaare Zedek Medical Center ( Site 1205)

location_facility: National Taiwan University Hospital ( Site 2301)

location_facility: Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)

location_facility: Auckland Clinical Studies Limited ( Site 1600)

location_facility: Ege University Medical Faculty ( Site 2404)

location_facility: CHU de Nice Hopital de l Archet II ( Site 0800)

location_facility: Hiroshima University Hospital ( Site 1413)

location_facility: Pan American Center for Oncology Trials ( Site 3102)

location_facility: Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)

location_facility: Hospital Regional de Concepcion ( Site 0505)

location_facility: Scientific research center ECO-security ( Site 1920)

location_facility: hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)

location_facility: Hopital de la Pitie Salpetriere ( Site 0813)

location_facility: The First People's Hospital of Foshan-Infection Department ( Site 0612)

location_facility: Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)

location_facility: Texas Clinical Research Institute ( Site 2619)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)

location_facility: Royal Prince Alfred Hospital ( Site 0102)

location_facility: Klinical Investigations Group ( Site 3100)

location_facility: C.H.U. Nancy Hopital de Brabois ( Site 0803)

location_facility: Hanyang University Seoul Hospital ( Site 2002)

location_facility: Aichi Medical University Hospital ( Site 1402)

location_facility: Ocean Blue Medical Research Center Inc ( Site 2667)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)

location_facility: American Research Corporation at Texas Liver Institute ( Site 2634)

location_facility: Clinical Research Chile SpA ( Site 0506)

location_facility: Nara Medical University Hospital ( Site 1407)

location_facility: Korea University Guro Hospital ( Site 2004)

location_facility: Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)

location_facility: Sweet Hope Research Specialty Inc ( Site 2660)

location_facility: The Affiliated Hospital of Hangzhou Normal University ( Site 0600)

location_facility: Virginia Commonwealth University Health System ( Site 2657)

location_facility: A.P.H. Paris, Hopital Saint Antoine ( Site 0807)

location_facility: Kawasaki Medical School General Medical Center ( Site 1412)

location_facility: Osaka City University Hospital ( Site 1415)

location_facility: National Cheng Kung University Hospital ( Site 2304)

location_facility: Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)

location_facility: Hospital Universitario Austral ( Site 0003)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0501)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 1300)

location_facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)

location_facility: Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)

location_facility: Excel Clinical Research, LLC ( Site 2603)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)

location_facility: Del Sol Research Management ( Site 2674)

location_facility: SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)

location_facility: Hospital San Juan de Dios de La Serena ( Site 0500)

location_facility: Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)

location_facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)

location_facility: Seoul National University Hospital ( Site 2003)

location_facility: Peak Gastroenterology Associates ( Site 2645)

location_facility: CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)

location_facility: Ankara University Cebeci Research and Application Hospital ( Site 2406)

location_facility: Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)

location_facility: McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 0400)

location_facility: The Liver Institute at Methodist Dallas Medical Center ( Site 2638)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)

location_facility: Catalina Research Institute, LLC ( Site 2643)

location_facility: Hospital Clinico Universitario de Santiago ( Site 2104)

title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.

summary: This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.


title: A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

summary: The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Italy
Austria
Spain
Germany
Finland
France
Japan
Poland
Israel
Norway
Hungary
Belgium
Romania
China
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: New Jersey Hematology Oncology Associates Llc

location_facility: Hospital General Universitario Vall D Hebron

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

location_facility: Tongji Hospital Huazhong University of Science and Technology

location_facility: A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi

location_facility: Hadassah Hebrew University Medical Center Ein Karem

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Tianjin Medical University General Hospital

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

location_facility: Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

location_facility: Bagcilar Medipol Mega University Hospital

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Pek

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Westchester Medical Center Advanced Oncology

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: The Second Affiliated Hospital of Xi an Jiaotong University

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Xuanwu Hospital Capital Medical University

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Shanghai Jiao Tong University Ruijin Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: The Catholic University of Korea Seoul St. Mary'S Hospital

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Ondokuz Mays University Medicine Faculty

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: The Second Affiliated Hospital of Kunming Medical University

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Univ. Di Roma Facolta Di Armacia E Medicina

location_facility: The Second Affiliated Hospital of Dalian Medical University

location_facility: National Cheng Kung University (Ncku) Hospital

location_facility: Harbin Institute of Hematology and Oncology

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

location_facility: Stamford Hospital - Medical Oncology Hematology

location_facility: Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

location_facility: Istanbul Medipol Universitesi - Bagcilar Medipol Mega Universitesi Hastanesi

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: The First Hospital of China Medical University

location_facility: Spitalul Clinic Coltea - Clinica Hematologie

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital General Unviersitario de Alicante

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: The First Hospital of Lanzhou University

location_facility: Samodzielny Puliczny Szpital Kliniczny im. Andrzeja Mielckiego

location_facility: Fujian Medical University Union Hospital

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon


lead_sponsor: Genfit

location_country:
Italy
United States
Brazil
South Africa
Switzerland
Germany
France
Belgium
Argentina
Spain
Canada
United Kingdom

acronym: ELATIVE

location_facility: University of Colorado Denver and Hospital

location_facility: Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond

location_facility: Texas Digestive Disease Consultants dba GI Alliance

location_facility: NYU Langone Health / NYU Grossman School of Medicine

location_facility: Hospital Universitario Puerta de Hierro -Madrid

location_facility: Medical University of South Carolina- College of Medicine

location_facility: Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital

location_facility: The New York-Presbyterian Hospital, David H. Koch Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Plymouth Hospitals NHS Trust, Derriford Hospital

location_facility: The Ohio State University Wexner Medical Center

location_facility: Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Center for Gastroenterology and Hepatology (GHZ) Kiel

location_facility: The University of Texas Southwestern Medical Center-IDS Aston Pharmacy

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica

location_facility: Groote Schuur Hospital, University of Cape Town - Clinical Research Centre

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

location_facility: CHU Grenoble Alpes - Hôpital Albert Michallon

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Belfast Health and Social Care Trust-Royal Victoria Hospital

location_facility: University of California, Davis Medical Center

location_facility: Columbia University Medical Center - Center for Liver Disease and Transplantation

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation

location_facility: Yale School of Medicine, Digestive Diseases

location_facility: Intermountain Medical Center - Transplant Services

location_facility: Encore Borland-Groover Clinical Research

location_facility: University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: Virginia Commonwealth University Clinical Research Services Unit (CRSU)

location_facility: Frimley Health NHS Foundation Trust - Frimley Park Hospital

location_facility: Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale

location_facility: King's College Hospital. King's College NHS Foundation Trust

ipd_sharing: Undecided

title: A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid

summary: The main objective of the study is to evaluate the effect of daily oral administration of 80mg elafibranor on cholestasis (impairment of bile formation and/or bile accumulation) in patients with PBC and inadequate response or intolerance to Ursodeoxycholic Acid (UCDA)


title: A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants

summary:
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study.

Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only.

Participants take BI 1358894, quetiapine, or placebo as tablets twice a day. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine.

Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms.

The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

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:
United States
France
Czechia
Japan
Poland
Slovakia
Hungary
Australia
Russian Federation
Spain
Germany

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: Peninsula Therapeutic and Research Group

location_facility: Federal State Budget Institution "Mental Health Research Center"

location_facility: SHI "Reg.Clin.Psychiatric Hosp.of Saint Sophia"

location_facility: SBI of HC "Z. P. Solovyov Scientific&pract psychoneurolog.Cent"

location_facility: National Center for Global Health and Medicine Kohnodai Hospital

location_facility: FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Praxis für Psychiatrie und Psychotherapie

location_facility: CENTRUM ZDRAVIA R.B.K, s.r.o., psychiatric clinic

location_facility: Osrodek Badan Klinicznych CLINSANTE S.C.

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: University of Kansas School of Medicine-Wichita

location_facility: The Ohio State University Wexner Medical Center

location_facility: Specialist Psychiatric Healthcare Centre in Lodz

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: FSBI V. P. Serbsky Nat.Med.Res.Cen.of Psych&Neuro

location_facility: Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun

location_facility: FSBEI of HE Smolensk State Medical University

location_facility: National Center Neurology and Psychiatry

location_facility: SBHI "Psychiatric Hospital #1 P.P.Kashchenko"


ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
France
Czechia
Belgium
Russian Federation
Spain
United States
United Kingdom

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Dept. of Oncology Faculty Hospital Motol

location_facility: Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

location_facility: Russian Cancer research center n.a. N.N. Blokhin

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: VHIO Valle de Hebron Instituto de Oncologia

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhina" of the MoH of the RF

location_facility: Foundation IRCCS Casa Sollievo della Sofferenza

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: Istituto Nazionale Tumori, Fondazione G. Pascale Napoli

location_facility: SAHI Republican Clinical Oncology Dispensary

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: University of California, Los Angeles (UCLA)

location_facility: Fondazione IRCCS - Istituto Tumori Milano

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chiara

location_facility: Arkangelsk Clinical Oncological Dyspensary

title: A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE)

summary: The purpose of this study is to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification.


title: A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis

acronym: NAVIGATE

summary: This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

lead_sponsor: Galectin Therapeutics Inc.

location_country:
United States
Mexico
Germany
France
Poland
Israel
Belgium
Australia
Puerto Rico
Spain
Canada
United Kingdom

location_facility: University of Cincinnati Physicians Company, LLC

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: Bon Secours Liver Institute of Virginia - Newport News

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices

location_facility: Clinique Universitaire De Bruxelles Hôpital Erasme VZW

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Gastroenterology Associates of Western Michigan

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University Diabetes & Endocrine Consultants

location_facility: The Jefferson Digestive Health Institute - Thomas Jefferson University

location_facility: University of Utah Health Care - UUHC - Kidney & Liver Clinic

location_facility: Southern Therapy and Advanced Research (STAR) - Jackson

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Medyczny Katedra i Klinika Chorób Zakaźnych, Chorób Wątroby i Nabytych Niedoborów Odpornościowych

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Groupe sante CHC - Clinique du MontLegia

location_facility: Mercy Medical Center - The Institute for Digestive Health and Liver Disease

location_facility: Pioneer Research Solutions Inc - Houston - Stancliff Rd

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: The University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit

location_facility: Bon Secours Liver Institute of Virginia - Richmond

location_facility: SP CSK im Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases

location_facility: King's College Hospital NHS Foundation Trust

location_facility: University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Henry Ford Health System - Hemophilia and Thrombosis Treatment Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: Gastroenterology Associates of Fredericksburg

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: The Chaim Sheba Medical Center - The Center for Liver Diseases

location_facility: NewYork-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: University of Virginia School of Medicine

location_facility: Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park

location_facility: Integrity Clinical Research, LLC (ICR SITES) - Doral

location_facility: University Hospitals Cleveland Medical Center

location_facility: Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic


title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)

acronym: CheckMate 74W

summary: The purpose of this study is to compare effectiveness and safety of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Hong Kong
Spain
Switzerland
Germany
France
Czechia
Japan
Poland
Singapore
Australia
Belgium
Puerto Rico
China
Russian Federation
Canada
Korea, Republic of
Taiwan

location_facility: Universite Libre de Bruxelles (ULB) - Hopital Erasme

location_facility: Kyoto Prefectural University of Medicine KPUM - University Hospital

location_facility: Hospital General Universitario Gregorio Maranon HGUGM

location_facility: Parc Tauli Sabadell Hospital Universitari

location_facility: Centre Hospitalier Universitaire de Nantes CHU de Nantes

location_facility: A.M.Granovs Russian Scientific Center of Radiology and Surgical Technologies

location_facility: University of Louisville-James Graham Brown Cancer Center

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Universitatsmedizin Gttingen - Universitat GeottingenKlinik fuer Gastroenterologie und Gastrointesti

location_facility: Cliniques Univ St Luc - Gastro-Enterology

location_facility: Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Affilie Universitaire - Hotel-Dieu de Quebec

location_facility: Universitatsklinikum St. Polten - Lilienfeld Standort St. Polten

intervention_type: Biological


title: A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

acronym: PANAMO

summary:
Phase II & Phase III:

This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)

ReferenceType: derived

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Kreuzberger

full_name: Nina Kreuzberger

given: Nina

family: Hirsch

full_name: Caroline Hirsch

given: Caroline

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

family: Chai

full_name: Khai Li Chai

given: Khai Li

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

family: Tomlinson

full_name: Eve Tomlinson

given: Eve

family: Khosravi

full_name: Zahra Khosravi

given: Zahra

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

family: Popp

full_name: Maria Popp

given: Maria

family: Neidhardt

full_name: Miriam Neidhardt

given: Miriam

family: Piechotta

full_name: Vanessa Piechotta

given: Vanessa

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Salomon

full_name: Susanne Salomon

given: Susanne

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

family: Valk

full_name: Sarah J Valk

given: Sarah J

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

family: Schmaderer

full_name: Christoph Schmaderer

given: Christoph

family: Wood

full_name: Erica M Wood

given: Erica M

name: Erasmus Medical Centre; Rotterdam Netherlands

family: So-Osman

full_name: Cynthia So-Osman

given: Cynthia

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

family: Roberts

full_name: David J Roberts

given: David J

family: McQuilten

full_name: Zoe McQuilten

given: Zoe

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Vlaar APJ, de Bruin S, Busch M, Timmermans SAMEG, van Zeggeren IE, Koning R, Ter Horst L, Bulle EB, van Baarle FEHP, van de Poll MCG, Kemper EM, van der Horst ICC, Schultz MJ, Horn J, Paulus F, Bos LD, Wiersinga WJ, Witzenrath M, Rueckinger S, Pilz K, Brouwer MC, Guo RF, Heunks L, van Paassen P, Riedemann NC, van de Beek D. Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial. Lancet Rheumatol. 2020 Dec;2(12):e764-e773. doi: 10.1016/S2665-9913(20)30341-6. Epub 2020 Sep 28.

family: Vlaar

full_name: Alexander P J Vlaar

given: Alexander P J

family: de Bruin

full_name: Sanne de Bruin

given: Sanne

family: Busch

location_country:
Brazil
Peru
South Africa
Mexico
Netherlands
France
Belgium
Russian Federation
Germany

location_facility:
University Greifswald
University Lima II
University Culiacan
University Brussels
University Leuven
Inflarx site
University Nice
Inflarx
University Moscow
University of Peru
Hospital Grenoble
University Nuevo Leon Monterrey
University Paris 1
University St. Etienne
University Paris 2
University Ryazan
University Augsburg
University Nantes
University Simon Campos
University Porto Alegre
University Suresnes
University Paris 3
Inflarx Site
University Eindhoven
University Dresden
University Aachen
University of Somerset West
University of Chiuhuahua
University Berlin- Charite


title: Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

summary: The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

status: Approved for marketing

study_type: Expanded Access

lead_sponsor: Gilead Sciences

location_country:
Greece
Romania
Australia
Belgium
Denmark
Iceland
France
Poland
Lithuania
Slovakia
Canada
Slovenia
Switzerland
Netherlands
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Austria
Cyprus
Czechia
Israel
Spain
Estonia

location_facility: Spitalul Clinic de Boli Infecţioase Sfânta Parascheva Iaşi

location_facility: NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital

location_facility: Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zakład Opiekuńczo Leczniczy

location_facility: Hackensack Meridian Health - JFK Medical Center

location_facility: Memorial Health University Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Centro Hospitalar Universitário De São João

location_facility: General Hospital of Thessaloniki George Papanikolaou

location_facility: Stony Brook University Hospital/ Stony Brook Children's

location_facility: Universitätsklinik für Innere Medizin II

location_facility: Centro Hospitalar Universitário do Porto E.P.E.

location_facility: Piedmont Columbus Regional-Midtown Hospital

location_facility: Brookdale University Hospital and Medical Center

location_facility: University of Washington Medical Center- Montlake Campus

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Centro Hospitalar Universitário de Lisboa Central - Hospital Curry Cabral

location_facility: The Ohio State University College of Medicine

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Robert Wood Johnson University Hospital Hamilton

location_facility: Our Lady of the Lakes Regional Medical Center

location_facility: Atlantic Health System/Overlook Medical Center

location_facility: University Hospital Brooklyn (SUNY Downstate)

location_facility: Univerzitná Nemocnica L. Pasteura Košice - Pracovisko Rastislavova 43

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Wojewódzki Szpital Specjalistyczny Megrez Sp. z o.o.

location_facility: Grady Health System- Grady Memorial Hospital

location_facility: Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital

location_facility: Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest

location_facility: Mercy Catholic Medical Center - Fitzgerald Campus

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Banner- University Medical Center Phoenix

location_facility: University Hospital of Wales, Cardiff and Vale NHS Trust

location_facility: Hospital Universitario Central de Asturias

location_facility: Texas Health Presbyterian Hospital Dallas

location_facility: Northwestern Medicine Central DuPage Hospital

location_facility: New York Presbyterian Lower Manhattan Hospital

location_facility: NewYork-Presbyterian Brooklyn Methodist Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

location_facility: University of California, Medical Center (Parnassus Campus)

location_facility: AdventHealth Orlando, Investigational Drug Services

location_facility: Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef-Spital

location_facility: Saint Josef Hospital Ruhr Universitaet Bochum

location_facility: New York City Health and New York City Health and Hospitals - Metropolitan- Metropolitan

location_facility: Washington University School of Medicine

location_facility: University General Hospital of Patras Panagia I Voithia

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Montefiore Medical Center, Weiler Campus

location_facility: Medical University and General Hospital Vienna

location_facility: Clinical hospital for infectious disease

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Staten Island University Hospital- Northwell Health (North Campus)

location_facility: Montefiore Health System Moses Medical Center

location_facility: New York City Health + Hospitals / Harlem

location_facility: Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho

location_facility: Community Regional Medical Centers (CRMC)

location_facility: Atlantic Health System/ Morristown Medical Center

location_facility: Centre Hospitalier Universitaire Gabriel-Montpied

location_facility: Eticka komise pro multicentircke klinicke hodnoceni Fakultni nemocnice v Motole

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Steward St. Elizabeth's Medical Center of Boston, Inc.

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: University of Maryland St. Joseph Medical Center

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: New York City Health and Hospitals - Coney Island

location_facility: The Stamford Health Medical Group- Pulmonary Associates

location_facility: St. Vincent Hospital and Health Care Center, Inc.

location_facility: Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch

location_facility: Wayne Statue University/ Detroit Receiving Hospital

status_simplified: Unknown


title: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

acronym: ENHANCE

summary: The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

location_country:
Italy
Austria
United States
Hong Kong
Spain
Switzerland
Finland
France
Poland
Norway
Hungary
Australia
Belgium
New Zealand
Portugal
Canada
United Kingdom

location_facility: The Ohio State University Wexner Medical Center / James Cancer Hospital

location_facility: Centro Hospitalar Universitario Sao Joao. E.P.E

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: The University of Chicago Medical Center

location_facility: Texas Oncology - Baylor Charles A. Simmons Cancer Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: University of California, Davis Comprehensive Cancer Center

location_facility: University of Minnesota Medical Center, Fairview

location_facility: Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

location_facility: SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: University of Oklahoma Health Sciences Center

location_facility: Weill Cornell Medicine-New York Presbyterian Hospital

location_facility: Centro Clinico Academico de Braga, Hospital de Braga, E.P.E

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital of the University of Pennsylvania

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization

location_facility: University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center

location_facility: U.O Ematologica- ASST degli Spedali Civili di Brescia

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Institut Catala d'Oncologia, Hospital Duran i Reynals

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: CHU de Poitiers - Hopital de la Miletrie

location_facility: Froedtert Hospital & the Medical College of Wisconsin

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Arkansas for Medical Sciences IRB

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita

location_facility: The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu

location_facility: U.O di Ematologia, Ospedale San Gerardo- ASST Monza

location_facility: Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Oregon Health & Science University Pharmacy Services

location_facility: University of Kansas Clinical Research Center

location_facility: Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly

location_facility: Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: SC di Oncoematologia - Azienda Ospedaliera Santa Maria

location_facility: Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Barwon Health, University Hospital Geelong


title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

summary: Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.

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: AstraZeneca

location_country:
Italy
United States
Peru
Spain
Germany
France
Japan
Poland
Israel
Hungary
Belgium
Argentina
Australia
China
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan


ReferenceCitation: Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marté JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.

family: Strauss

full_name: Julius Strauss

given: Julius

family: Heery

full_name: Christopher R. Heery

given: Christopher R.

family: Schlom

full_name: Jeffrey Schlom

given: Jeffrey

family: Madan

full_name: Ravi A. Madan

given: Ravi A.

family: Cao

full_name: Liang Cao

given: Liang

family: Kang

full_name: Zhigang Kang

given: Zhigang

family: Lamping

full_name: Elizabeth Lamping

given: Elizabeth

family: Marté

full_name: Jennifer L. Marté

given: Jennifer L.

family: Donahue

full_name: Renee N. Donahue

given: Renee N.

family: Grenga

full_name: Italia Grenga

given: Italia

family: Cordes

full_name: Lisa Cordes

given: Lisa

family: Christensen

full_name: Olaf Christensen

given: Olaf

family: Mahnke

full_name: Lisa Mahnke

family: Helwig

full_name: Christoph Helwig

family: Gulley

full_name: James L. Gulley

given: James L.

journal_name: Clinical Cancer Research

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

version: acceptedVersion

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J, Yu H, Qin G, Sircar A, Hernández VM, Jenkins MH, Fontana RE, Deshpande A, Locke G, Sabzevari H, Radvanyi L, Lo KM. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-β. Sci Transl Med. 2018 Jan 17;10(424). pii: eaan5488. doi: 10.1126/scitranslmed.aan5488.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

location_country:
Brazil
Spain
France
Japan
Hungary
Belgium
Argentina
Australia
China
Russian Federation
United States
Korea, Republic of

acronym: Phase II Bintrafusp alfa Monotherapy in Platinum-Experienced Cervical Cancer

location_facility: NHO Kyushu Cancer Center - Dept of Gynecology

location_facility: Kurume University Hospital - Dept of Gynecology

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Hospital Universitario Ramon y Cajal - Servicio de Oncologia

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Stanford University Hospital and Clinics - Stanford Cancer Center

location_facility: University Hospital, University of the Ryukyus - Dept of Obstetrics/Gynecology

location_facility: Jikei University Hospital - Dept of Gynecology

location_facility: Centre Hospitalier Lyon Sud - service d'oncologie medicale

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Orszagos Onkologiai Intezet - Nogyogyaszati Osztaly

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

location_facility: Centre Oscar lambret - Service d'Oncologie medicale

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Universitair Ziekenhuis Gent - Pneumology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Saitama Medical University International Medical Center - Dept of Gynecology/Oncology

location_facility: Osaka International Cancer Institute - Dept of Gynecology

location_facility: Institut Jean Godinot - Service d'hématologie et Oncologie Médicale

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: National Cancer Center Hospital - Dept of Mammary Gland/Oncology

location_facility: Cancer Institute Hospital of JFCR - Dept of Gynecology

location_facility: Clinica Universidad de Navarra (MAD) - Oncology Service

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: NHO Hokkaido Cancer Center - Dept of Gynecology

location_facility: Kanagawa Cancer Center - Dept of Gynecology

location_facility: AZ Groeninge - Campus Kennedylaan - account 2

location_facility: Hôpital Cochin - Hematologie et Oncologie Médicale

location_facility: Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

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

location_facility: ICO Girona - Hospital Doctor Josep Trueta - Servicio de Oncologia Medica

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz - Onkoradiologia

title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy

summary: The main purpose of this study is to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.


location_country:
Italy
United States
Chile
South Africa
Germany
France
Japan
Israel
Argentina
Spain
Canada
Taiwan
Colombia

acronym: Randomized, double blind, safety, efficacy Doravirine/Islatravir in Tx naïve

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69

location_facility: Ruane Clinical Research Group, Inc. ( Site 5624)

location_facility: Hospital Universitario La Paz ( Site 6304)

location_facility: National Cheng Kung University Hospital ( Site 7101)

location_facility: Hospital Clinic i Provincial ( Site 6300)

location_facility: EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)

location_facility: Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)

location_facility: Floridian Clinical Research, LLC ( Site 5625)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)

location_facility: Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)

location_facility: Hospital Clinico de la Universidad Catolica ( Site 5903)

location_facility: Hospital Universitario San Ignacio ( Site 6005)

location_facility: Centre Hospitalier Regional du Orleans ( Site 6108)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)

location_facility: North Texas ID Consultants, PA ( Site 5604)

location_facility: Clinica Universidad Catolica del Maule ( Site 5909)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 6301)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 6903)

location_facility: Hospital Universitari de Bellvitge ( Site 6312)

location_facility: Azienda Ospedaliera San Paolo ( Site 6403)

location_facility: Hospital Universitario 12 de Octubre ( Site 6305)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)

location_facility: Texas Centers for Infectious Disease Associates P.A. ( Site 5619)

location_facility: Chris Hani Baragwanath Hospital - ICU ( Site 6608)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)

location_facility: Midway Immunology and Research ( Site 5622)

location_facility: Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)

location_facility: National Taiwan University Hospital ( Site 7100)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 6303)

location_facility: Hopital Francois Mitterrand ( Site 6119)

location_facility: Universitaetsklinik Freiburg ( Site 6206)

location_facility: Ospedale San Gerardo ASST Monza ( Site 6412)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)

location_facility: Infectious Disease Specialists Of Atlanta PC ( Site 5608)

location_facility: Centre Hospitalier de Tourcoing ( Site 6100)

location_facility: A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 6114)

location_facility: Tokyo Medical University Hospital ( Site 6904)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)

location_facility: CHU de Bordeaux. Hopital Pellegrin ( Site 6116)

location_facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 6309)

location_facility: Triple O Research Institute, P.A. ( Site 5621)

location_facility: Toronto General Hospital - University Health Network ( Site 5705)

location_facility: Chaim Sheba Medical Center. ( Site 6704)

location_facility: University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)

location_facility: Kumamoto University Hospital ( Site 6905)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 5905)

location_facility: Kaohsiung Veterans General Hospital ( Site 7102)

location_facility: Saint Hope Foundation, Inc. ( Site 5629)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 6901)

location_facility: Centro Cardiovascular Cardiosur ( Site 5907)

location_facility: Hadassah Ein Kerem Medical Center ( Site 6702)

location_facility: McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)

location_facility: Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)

location_facility: Columbus Regional Research Institute ( Site 5616)

location_facility: Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)

location_facility: IRCCS Policlinico San Matteo ( Site 6410)

title: A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants

summary: This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.


title: VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis

acronym: VOYAGE

summary: The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.

lead_sponsor: Viking Therapeutics, Inc.

location_country:
Mexico
France
Puerto Rico
Belgium
United States

location_facility:
Viking Clinical Site 604
Viking Clinical Site 137
Viking Clinical Site 112
Viking Clinical Site 304
Viking Clinical Site 105
Viking Site 155
Viking Clinical Site 201
Viking Clinical Site 607
Viking Clinical Site 401
Viking Clinical Site 217
Viking Clinical Site 102
Viking Clinical Site 225
Viking Clinical Site 160
Viking Clinical Site 116
Viking Clinical Site 501
Viking Clinical Site 128
Viking Clinical Site 163
Viking Clinical Site 221
Viking Clinical Site 130
Viking Clinical Site 301
Viking Clinical Site 602
Viking Clinical Site 306
Viking Clinical Site 314
Viking Clinical Site 127
Viking Clinical Site 219
Viking Clinical Site 113
Viking Clinical Site 125
Viking Clinical Site 214
Viking Clinical Site 307
Viking Clinical Site 156
Viking Clinical Site 609
Viking Clinical Site 206
Viking Clinical Site 216
Viking Clinical Site 502
Viking Clinical Site 611
Viking Clinical Site 166
Viking Clinical Site 146
Viking Clinical Site 159
Viking Clinical Site 135
Viking Clinical Site 142
Viking Clinical Site 503
Viking Clinical Site 129
Viking Clinical Site 143
Viking Clinical Site 151
Viking Clinical Site 612
Viking Clinical Site 311
Viking Clinical Site 153
Viking Clinical Site 316
Viking Clinical Site 305
Viking Clinical Site 205
Viking Clinical Site 218
Viking Clinical Site 147
Viking Clinical Site 610
Viking Clinical Site 402
Viking Clinical Site 126
Viking Clinical Site 601
Viking Clinical Site 111
Viking Clinical Site 209
Viking Clinical Site 204
Viking Clinical Site 133
Viking Clinical Site 144
Viking Clinical Site 131
Viking Clinical Site 202
Viking Clinical Site 158
Viking Clinical Site 115
Viking Clinical Site 302
Viking Clinical Site 421
Viking Clinical Site 154
Viking Clinical Site 118
Viking Clinical Site 110
Viking Clinical Site 103
Viking Clinical Site 310
Viking Clinical Site 215
Viking Clinical Site 313
Viking Clinical Site 161
Viking Clinical Site 152
Viking Clinical Site 312
Viking Clinical Site 603
Viking Clinical Site 101
Viking Clinical Site 108
Viking Clinical Site 141
Viking Clinical Site 213
Viking Clinical Site 212
Viking Clinical Site 106
Viking Clinical Site 120
Viking Clinical Site 605
Viking Clinical Site 117
Viking Clinical Site 220
Viking Clinical Site 148
Viking Clinical Site 132
Viking Clinical Site 134
Viking Clinical Site 226
Viking Clinical Site 208
Viking Clinical Site 211
Viking Clinical Site 107
Viking Clinical Site 422
Viking Clinical Site 109
Viking Clinical Site 317
Viking Clinical Site 121
Viking Clinical Site 145
Viking Clinical Site 315
Viking Clinical Site 150
Viking Clinical Site 227


title: A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

summary: The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.

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

lead_sponsor: GlaxoSmithKline

location_country:
Greece
Romania
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
Spain


intervention_type: Other

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
Finland
France
Czechia
Greece
Poland
Norway
Romania
Australia
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Dermatovenerologicka klinika VFN a 1. LF UK

location_facility: Medizinische Hochschule Hannover (Hannover Medical School)

location_facility: Hospital Regional Universitario De Malaga

location_facility: California Pacific Medical Center Research Institute

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Nationales Centrum Fur Tumorerkrankungen (Nct)

location_facility: Kaiser Permanente Medical Center (clinic+DSL)

location_facility: Nova Scotia Health Authority (Capital District Health Authority)

location_facility: Kaiser Permanente Oncology Clinical Trials

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Oddzial Onkologii Klinicznej i Doswiadczalnej

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Harry And Jeanette Weinberg Cancer Inst At Franklin Square

title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

summary: The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.


title: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)

summary: The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.

status: Terminated

study_completion_date_type: Actual

location_country:
Italy
Austria
United States
Spain
Germany
Finland
France
Japan
Poland
Slovakia
Romania
Ireland
Belgium
Portugal
Canada
United Kingdom

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Olsztynski Osrodek Onkologiczny Kopernik

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Istituto Nazionale Tumori Fondazione Irccs G. Pascale

location_facility: Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta

location_facility: Moncton Hospital - Horizon Health Network

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Charleston Hematology Oncology Associates

location_facility: Helsinki University Meilahti Tower Hospital

location_facility: Chu de Strasbourg Hopitaux Universitaires Service D Hematologie

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Institut Claudius Regaud Oncopole Toulouse

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Barts Health Nhs Trust - St Bartholomews Hospital

location_facility: Saitama Medical University International Medical Center

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: The Center For Cancer and Blood Disorders

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Christiana Care Helen F. Graham Cancer Center

location_facility: Cotton-O'Neil Clinical Research Center, Hematology & Oncology

location_facility: Hopital Europeen Georges Pompidou (Hegp)

location_facility: Fakultna Nemocnica S Poliklinikou Zilina

location_facility: Saitama Medical Center Jichi Medical University


title: A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis

acronym: GLOBOSTAD

summary:
Primary Objective:

To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD

Secondary Objectives:

To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching)
To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting
To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD
To collect safety data on study participants

study_type: Observational

time_perspective: Prospective

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/

lead_sponsor: Sanofi

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Kuwait
Norway
Argentina
Colombia
United Arab Emirates
Saudi Arabia
Netherlands
Portugal
Italy
Austria
Mexico
Czechia
Israel
Spain

location_facility: Investigational site United Arab Emirates