acronym: Olaparib Monotherapy in HRRm or HRD Positive Cancer

title: A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Japan
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Canada
Switzerland
Guatemala
Denmark
Ireland
Korea, Republic of
France
Colombia

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: Administradora Country SA - Clinica del Country ( Site 2802)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 0054)

location_facility: Policlinico Le Scotte di Siena ( Site 0704)

location_facility: Eastern Regional Medical Center, Inc. ( Site 0077)

location_facility: Herlev og Gentofte Hospital. ( Site 0401)

location_facility: Hopitaux Universitaires de Geneve HUG. ( Site 1406)

location_facility: Seoul National University Bundang Hospital ( Site 2402)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 1503)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)

location_facility: Northern Centre for Cancer Care ( Site 1602)

location_facility: Hospital Universitari Vall d Hebron ( Site 1350)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1207)

location_facility: University of Massachusetts ( Site 0017)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)

location_facility: Centre Georges Francois Leclerc ( Site 0608)

location_facility: Clinical Hospital Saint Luka ( Site 1205)

location_facility: Tallaght University Hospital ( Site 1652)

location_facility: Ege Universitesi Tip Fakultesi ( Site 1502)

location_facility: MNCCI Port Macquarie Base Hospital ( Site 2201)

location_facility: Southwestern Regional Medical Center, Inc. ( Site 0079)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1204)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 1206)

location_facility: Seoul National University Hospital ( Site 2401)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)

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

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 1504)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 2812)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)

location_facility: Oaxaca Site Management Organization S.C. ( Site 2905)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0801)

location_facility: Instituto de Investigaciones Metabolicas ( Site 2700)

location_facility: Hospital Central de la Fuerza Aerea del Peru ( Site 3104)

location_facility: Christie NHS Foundation Trust ( Site 1601)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 2907)

location_facility: Aichi Cancer Center Hospital ( Site 2602)

location_facility: St. Vincent's University Hospital ( Site 1653)

location_facility: C. Medico Imbanaco Cali S.A. ( Site 2810)

location_facility: VA New York Harbor Healthcare System Manhattan ( Site 0094)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 1500)

location_facility: Baskent University Adana Training Hospital ( Site 1508)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2809)

location_facility: Universitaetsspital Zuerich ( Site 1400)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)

location_facility: S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 1105)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0026)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)

location_facility: Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)

location_facility: Hospital Britanico de Buenos Aires ( Site 2704)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 3003)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)

location_facility: Clinica Internacional Sede San Borja ( Site 3100)

location_facility: Oncosalud-Clinical Research ( Site 3108)

location_facility: Sunnybrook Health Science Centre ( Site 0210)

location_facility: Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: National Cancer Center Hospital East ( Site 2600)

location_facility: Odense Universitetshospital ( Site 0400)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0056)

location_facility: Ryazan Regional Clinical Oncology dispensary ( Site 1202)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)

location_facility: Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)

location_facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)

location_facility: Linear Clinical Research Ltd ( Site 2202)

location_facility: Institut de Cancerologie Strasbourg Europe ( Site 0613)

location_facility: Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)

location_facility: Winship Cancer Institute of Emory University ( Site 0025)

location_facility: Cancer Partners of Nebraska ( Site 0051)

location_facility: Virginia Mason Medical Center ( Site 0052)

location_facility: Ospedale Regionale di Bellinzona e Valli ( Site 1407)

location_facility: Cedars Sinai Medical Center ( Site 0002)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0802)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)

location_facility: Hospital Universitario Quiron Madrid ( Site 1352)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0703)

location_facility: Mater Misericordiae University Hospital ( Site 1654)

location_facility: National Cancer Center Hospital ( Site 2601)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0011)

location_facility: Actualidad Basada en la Investigacion del Cancer ( Site 2903)

summary: This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).


title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

summary: This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Italy
Russian Federation
Netherlands
Canada
Sweden
Korea, Republic of
United States
France
Romania
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Active, not recruiting

acronym: ALPINE

title: A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

lead_sponsor: BeiGene

type: EudraCT Number

type: Registry Identifier

source: euctr

ReferenceType: result

ReferenceCitation: Hillmen P, Brown JR, Eichhorst BF, Lamanna N, O'Brien SM, Qiu L, Salmi T, Hilger J, Wu K, Cohen A, Huang J, Tam CS. ALPINE: zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Future Oncol. 2020 Apr;16(10):517-523. doi: 10.2217/fon-2019-0844. Epub 2020 Mar 24.

ReferenceType: derived

ReferenceCitation: Hillmen P, Eichhorst B, Brown JR, Lamanna N, O'Brien SM, Tam CS, Qiu L, Kazmierczak M, Zhou K, Šimkovič M, Mayer J, Gillespie-Twardy A, Shadman M, Ferrajoli A, Ganly PS, Weinkove R, Grosicki S, Mital A, Robak T, Österborg A, Yimer HA, Salmi T, Ji M, Yecies J, Idoine A, Wu K, Huang J, Jurczak W. Zanubrutinib Versus Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma: Interim Analysis of a Randomized Phase III Trial. J Clin Oncol. 2022 Nov 17:JCO2200510. doi: 10.1200/JCO.22.00510. [Epub ahead of print]

enrollment_type: Actual

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
New Zealand
Sweden
United States
France
China
Turkey
Belgium
Germany
Czechia

location_facility: VA Puget Sound Health Care System - NAVREF

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: University of California Irvine Medical Center

location_facility: New Jersey Hematology Oncology Associates LLC

location_facility: Quanzhou First Hospital of Fujian Province

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Gemeinschaftspraxis fur Hamatologie und Onkologie

location_facility: Onkoligische Gemeinschaftspraxis Dres. Dörfel/Göhler

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Comprehensive Cancer Centers of Nevada - USOR

location_facility: Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Texas Oncology - San Antonio Medical Center - USOR

location_facility: Fujian Medical University Union Hospital

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

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

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Shengjing Hospital of China Medical University

location_facility: The affiliated Hospital of Xuzhou Medical university

location_facility: Illinois Cancer Specialists (Niles) - USOR

location_facility: Beijing Friendship Hospital-Capital Medical University

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: The first affiliated hospital of Wenzhou Medical University

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Rocky Mountain Cancer Centers (Aurora) - USOR

location_facility: Greenville Health System Cancer Institute

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: The First affiliated hospital of Nanchang University

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hattiesburg Hematology and Oncology Clinic

location_facility: Hospital Universitario Central de Asturias

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

location_facility: Hospital Universitario Germans Trias i Pujol

summary: This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.


title: A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)

lead_sponsor: AstraZeneca

location_country:
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Korea, Republic of
United States
Chile
France
Turkey
Belgium
Japan
Germany
Slovakia
Czechia

summary: The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.


title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome

summary: This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

status: Completed

study_completion_date_type: Actual

ipd_sharing: No

lead_sponsor: PellePharm, Inc.

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

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University of Michigan, Dept of Dermatology

location_facility: Clinical Trials Unit - The Skin Care Centre

location_facility: Klinik und Poliklinik fur Dermatologie und Allergologie

location_facility: University of Miami Miller School of Medicine

location_facility: Hospital of the University of Pennsylvania

location_facility: Maastricht University Medical Center - Dept of Dermatology

location_facility: Ospedale Vanvitelli-University della Campania-Dermatologia Edificio 9

location_facility: Stanford University, Department of Dermatology

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Minnesota, Department of Dermatology

location_facility: Hospital Universitiario Virgen de la Macarena

location_facility: University of Utah Midvalley Dermatology

status_simplified: Completed


acronym: NOVA

title: A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

lead_sponsor: Biogen

ReferenceCitation: Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter G, Giovannoni G, Killestein J, Wiendl H, Smirnakis K, Xiao S, Kong G, Kuhelj R, Campbell N; NOVA study investigators. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):608-619. doi: 10.1016/S1474-4422(22)00143-0. Epub 2022 Apr 25.

ipd_sharing_description: Please refer data queries to DataSharing@biogen.com.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
United States
France
Israel
Belgium
Germany

location_facility:
Reseach Site
Research Site

summary:
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.

Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.


title: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)

summary: The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.

design_allocation: Non-Randomized

lead_sponsor: ADC Therapeutics S.A.

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: IRCCS istituto Clinico Humanitas U.O. di Oncologia ed Ematologia

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Centre Hospitalier Universitaire De Poitier - Hopital De La Miletrie - Hopital Jean Bernard

location_facility: The Blood and Marrow Transplant Group of Georgia

location_facility: University of Michigan Comprehensive Cancer Center

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

location_facility: University of California Irvine Health Chao Family Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Rennes Hôpital Pontchailou

location_facility: Azienda Unita Sanitaria Locale de Ravenna

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Georgia Cancer Center at Augusta University


title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)

acronym: Nefigard

summary: The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

ReferenceType: background

ReferenceCitation: Fellström BC, Barratt J, Cook H, Coppo R, Feehally J, de Fijter JW, Floege J, Hetzel G, Jardine AG, Locatelli F, Maes BD, Mercer A, Ortiz F, Praga M, Sørensen SS, Tesar V, Del Vecchio L; NEFIGAN Trial Investigators. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389(10084):2117-2127. doi: 10.1016/S0140-6736(17)30550-0. Epub 2017 Mar 28.

ReferenceCitation: Barratt J, Lafayette R, Kristensen J, Stone A, Cattran D, Floege J, Tesar V, Trimarchi H, Zhang H, Eren N, Paliege A, Rovin BH; NefIgArd Trial Investigators. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int. 2022 Oct 19. pii: S0085-2538(22)00836-5. doi: 10.1016/j.kint.2022.09.017. [Epub ahead of print]

lead_sponsor: Calliditas Therapeutics AB

location_country:
Poland
Taiwan
Belarus
Spain
Greece
Italy
Australia
United Kingdom
Argentina
Canada
Finland
Sweden
Korea, Republic of
United States
France
Turkey
Belgium
Germany
Czechia

location_facility: 4-th N.E. Savchenko City Clinical Hospital, 110, R. Luxemburg str.

location_facility: Northwestern University the Feinberg School of Medicine, 633 North St. Clair

location_facility: Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si

location_facility: Hospital Britanico de Buenos Aires, Pedriel 74

location_facility: Chu St Etienne-Hopital Nord, Service de Nephrologie Dialyse Transplantation renale, Av. Albert Raimond

location_facility: Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str.

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30

location_facility: Southeastern Nephrology-Whiteville, 800 Jefferson St

location_facility: Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12

location_facility: Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42

location_facility: University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10

location_facility: Hospital Universitario Austral, Unidad de Investigacion Clinica, Av. J.D. Peron 1500, piso 4

location_facility: Nephrology Associates, P.C., 28 White Bridge Rd

location_facility: General Hospital of Athens-Laiko, Nephrology Clinic, 17 Agiou Thoma Street

location_facility: Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street

location_facility: Mountain Kidney & Hypertension Assoc, 10 McDowell St

location_facility: Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str.

location_facility: Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12

location_facility: Hospital Privado-Centro Medico de Cordoba, Naciones Unidas 346, Nefrologia piso 1

location_facility: Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46

location_facility: China Medical University Hospital, No 2 Yude Rd

location_facility: Helsinki University Central Hospital (HUCH), Nephrology Clinic, Meilahti Triangle Hospital

location_facility: Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11

location_facility: Kidney Care and Transplant Services of New England, PC, 354 Birnie Av.

location_facility: Kaohsiung Medical Univ Chung-Ho Memorial Hospital

location_facility: Stanford University Medical Center, 777 Welch Rd

location_facility: Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20

location_facility: Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso

location_facility: Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849

location_facility: Prince of Wales Hospital, Nephrology Dept, Parkes 3 West

location_facility: Brest Regional Hospital, 7 Meditsinskaya str.

location_facility: Centre Hospitalier Boulogne sur Mer, 4eme etage Batiment Administratif, Allee Jacques Monod

location_facility: University General Hospital of Patras, Rio

location_facility: Clinico de Nefrologia, Urologia Y Enfermedades Cardiovasculares, Av. Gdor Freyre 3074

location_facility: Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive

location_facility: Allegheny General Hospital, 4800 Friendship Av.

location_facility: Ospedale San Carlo Borromeo, Via Pio II, 3

location_facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Centre

location_facility: University of Manchester, Manchester Royal Infirmary, Oxford Rd

location_facility: University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor

location_facility: Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53

location_facility: Yale University School of Medicine, 330 Cedar Street

location_facility: Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd

location_facility: University General Hospital of Ioannina, Nephrology Clinic, Leof. Stavros Niarchou

location_facility: Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences

location_facility: Oregon Health & Science University, 3181 SW Sam Jackson Park Rd

location_facility: Universitatsklinik Schleswig-Holstein-Campus Lubek, Medizinische Klinik I, Nephrologie, Ratzeburger Allee 160

location_facility: Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu

location_facility: CHU Grenoble-Hopital Michallon, Service Nephrologie-Hemodialyse-Aphereses-Transplantation Renale, Boulevard de la Chantourne CS 10217

location_facility: Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5

location_facility: Northshore University Health System, 2650 Ridge Av.

location_facility: Hospital Universitario Fundacion Alcorcon, C/Budapest 1

location_facility: University of Minnesota, 717 Delaware St. SE

location_facility: General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str.

location_facility: Renal Disease Research Institute, 1250 Eighth Av. #135

location_facility: Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd.

location_facility: Gloucestershire Royal Hospital, Great Western Rd

location_facility: Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden, Medizinische Klinik III, Nephrologie, Fetscherstr. 74

location_facility: Centre Hospitalier Universitaire de Liege, Nephrology Dept. Domaine Universitaire de Sart-Tilman

location_facility: Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2

location_facility: University of Colorado Health Science Center, 1200 East 19th Av.

location_facility: Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu

location_facility: Washington Nephrology Associates-Washington DC, 730 24th Street NW

location_facility: Danderyds sjukhus, Njurmedicinska kliniken

location_facility: Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu

location_facility: The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av.

location_facility: CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais

location_facility: Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129

location_facility: Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue

location_facility: Karolinska University Hospital-Huddinge, Njur-KBC M87

location_facility: Fakultni nemocnice Kralovske Vinohrady, Linterni klinika, Srobarova 1150/50

location_facility: Centre Hospitalier de Valenciennes, Service de Nephrologie-Medecine Interne, Av. Desandrouin BP 379

location_facility: Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str.

location_facility: Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str

location_facility: ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11

location_facility: Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18

location_facility: Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord

location_facility: Tampere University Hospital, P O Box 2000, Munuaiskeskus, Erakennus, 1. kerros

location_facility: CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd

location_facility: Royal Inland Hospital, Kidney Clinic, 7 South, 311 Columbia Street

location_facility: Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali

location_facility: Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi

location_facility: Fakultni nemocnice Hradec Kralove, Sokolska 581

location_facility: University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo

location_facility: Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu

location_facility: Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10

location_facility: Thomas Jefferson University, 211 S. 9th Street

location_facility: University of Alabama at Birmingham, 1720 2nd Ave South

location_facility: University Hospital of Heraklion, Nephrology Clinic, Diastaurosi Staurakion-Vouton

location_facility: Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola

location_facility: National Cheng Kung University Hospital, No 138 Sheng Li Rd

location_facility: Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place

location_facility: Hopital Bichat-Claude Bernard, Service de Nephrologie, 46 rue Henri Huchard

location_facility: Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n

location_facility: Cliniques Universitaires Saint-Luc, Nephrology Dept, Av. Hippocrate 10

location_facility: Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251

location_facility: Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St.

location_facility: Queen Elizabeth II Health Sciences Centre, 1276 South Park St

location_facility: Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170

location_facility: Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego

location_facility: Lapeyronie Hospital, Univ Hospital Montpellier, 371 Av. du Doyen Gaston Giraud

location_facility: Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu

location_facility: Clinical Research Consultants, LLC, 3930 Washington St

location_facility: Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building

location_facility: Omega Research Maitland, 7912 Forest City Rd.

location_facility: Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5

location_facility: University Hospital Erasmus (Brussels), Recherche Clinique Nephrologie Transplantation, Route de Lennik 808

location_facility: St James´s University Hospital, Beckett St.

location_facility: Southmead Hospital, Southmead Rd, Westbury-on-Trym

location_facility: Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18

location_facility: Universitaetsklinikum Heidelberg-Nephrologie, Renal Clinic, Im Neuenheimer Feld 162

location_facility: University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV

location_facility: Austin Health, Dept of Nephrology, 145 Studley Rd.

location_facility: Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80

location_facility: Ege University Med Faculty Dept of Internal Disease, Div of Nephrology

location_facility: Fakultni nemocnice Olomouc, I.P. Pavlova 185/6

location_facility: Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd.

location_facility: Universitetssjukhuset Linköping, Njurmedicinska kliniken

location_facility: Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av.


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

ReferenceCitation: Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.

ReferenceCitation: Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Spain
Italy
Austria
Russian Federation
Hungary
United States
France
Israel
Peru
Mexico
Japan
Germany
Turkey
Bulgaria
Slovakia

location_facility: Spec. Ophth. Hospital for Active Treatment- Academic Pashev

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hospital Universitario de Gran Canaria; Servicio de oftalmologia

location_facility: Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Retina Consultants of Southern California

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: University of Utah; Division of Gastroenterology/Hepatology

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: Beetham Eye Institute, Joslin Diabetes Center

location_facility: Tokyo Women's Medical University Hospital

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

location_facility: California Eye Specialists Medical group Inc.

location_facility: Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: Shiga University Of Medical Science Hospital

location_facility: Centre Odeon; Exploration Ophtalmologique

location_facility: Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Medical Center for Eye Health - Focus Ltd

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: National Defense Medical College Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

location_facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

location_facility: University of California, Davis, Eye Center

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

location_facility: Instituto Mexicano de Oftalmologia I.A.P.

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

intervention_type: Procedure


acronym: Expedition

title: A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)

type: Other Identifier

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:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Puerto Rico
India
Israel
Slovakia
Canada
Hungary
Germany
Bulgaria
Taiwan
Korea, Republic of
France

summary: The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.


title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

summary:
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

ReferenceCitation: Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.

ReferenceCitation: Skoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, Italiano A, Schuler M, Borghaei H, Barlesi F, Kato T, Curioni-Fontecedro A, Sacher A, Spira A, Ramalingam SS, Takahashi T, Besse B, Anderson A, Ang A, Tran Q, Mather O, Henary H, Ngarmchamnanrith G, Friberg G, Velcheti V, Govindan R. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021 Jun 24;384(25):2371-2381. doi: 10.1056/NEJMoa2103695. Epub 2021 Jun 4.

ReferenceCitation: Fakih MG, Kopetz S, Kuboki Y, Kim TW, Munster PN, Krauss JC, Falchook GS, Han SW, Heinemann V, Muro K, Strickler JH, Hong DS, Denlinger CS, Girotto G, Lee MA, Henary H, Tran Q, Park JK, Ngarmchamnanrith G, Prenen H, Price TJ. Sotorasib for previously treated colorectal cancers with KRAS(G12C) mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):115-124. doi: 10.1016/S1470-2045(21)00605-7. Epub 2021 Dec 15.

ReferenceCitation: Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRAS(G12C) Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. doi: 10.1056/NEJMoa1917239. Epub 2020 Sep 20.

ReferenceCitation: Zhao Y, Murciano-Goroff YR, Xue JY, Ang A, Lucas J, Mai TT, Da Cruz Paula AF, Saiki AY, Mohn D, Achanta P, Sisk AE, Arora KS, Roy RS, Kim D, Li C, Lim LP, Li M, Bahr A, Loomis BR, de Stanchina E, Reis-Filho JS, Weigelt B, Berger M, Riely G, Arbour KC, Lipford JR, Li BT, Lito P. Diverse alterations associated with resistance to KRAS(G12C) inhibition. Nature. 2021 Nov;599(7886):679-683. doi: 10.1038/s41586-021-04065-2. Epub 2021 Nov 10.

ReferenceCitation: Lanman BA, Allen JR, Allen JG, Amegadzie AK, Ashton KS, Booker SK, Chen JJ, Chen N, Frohn MJ, Goodman G, Kopecky DJ, Liu L, Lopez P, Low JD, Ma V, Minatti AE, Nguyen TT, Nishimura N, Pickrell AJ, Reed AB, Shin Y, Siegmund AC, Tamayo NA, Tegley CM, Walton MC, Wang HL, Wurz RP, Xue M, Yang KC, Achanta P, Bartberger MD, Canon J, Hollis LS, McCarter JD, Mohr C, Rex K, Saiki AY, San Miguel T, Volak LP, Wang KH, Whittington DA, Zech SG, Lipford JR, Cee VJ. Discovery of a Covalent Inhibitor of KRAS(G12C) (AMG 510) for the Treatment of Solid Tumors. J Med Chem. 2020 Jan 9;63(1):52-65. doi: 10.1021/acs.jmedchem.9b01180. Epub 2019 Dec 24.

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

lead_sponsor: Amgen

location_country:
Brazil
Portugal
Romania
Greece
Austria
Australia
Spain
Canada
Switzerland
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

location_facility: American Oncology Partners of Maryland, PA

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Hospital General Universitario de Valencia

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: McGill University Health Centre Glen Site

location_facility: Klinikum der Universität München Campus Grosshadern

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Duke University Medical Center, Morris Cancer Clinic

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Vanderbilt University Ingram Cancer Center

location_facility: US Oncology Research Investigational Products Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Gibbs Cancer Center and Research Institute - Spartanburg

location_facility: Seoul National University Bundang Hospital

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center

location_facility: Institutul Oncologic, Prof Dr Alexandru Trestioreanu

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Severance Hospital Yonsei University Health System

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Laura and Isaac Perlmutter Cancer Center at New York University Langone

location_facility: Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: University of Texas Southwestern Medical Center


status: Terminated

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis

lead_sponsor: Sanofi

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://vivli.org

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Portugal
Slovenia
Russian Federation
Australia
Argentina
Israel
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Estonia
France
Netherlands

location_facility:
Investigational Site Number 3760004
Investigational Site Number 6430002
Investigational Site Number 2500002
Investigational Site Number 5280001
Investigational Site Number 0360006
Investigational Site Number 7520001
Investigational Site Number 8260003
Investigational Site Number 0360003
Investigational Site Number 2500003
Investigational Site Number 0560001
Investigational Site Number 5280009
Investigational Site Number 6200005
Investigational Site Number 7240015
Investigational Site Number 6430005
Investigational Site Number 5280005
Investigational Site Number 8400019
Investigational Site Number 2500001
Investigational Site Number 7520003
Investigational Site Number 2760003
Investigational Site Number 2760007
Investigational Site Number 8400014
Investigational Site Number 1910001
Investigational Site Number 2760002
Investigational Site Number 3760006
Investigational Site Number 1240003
Investigational Site Number 2080003
Investigational Site Number 2500007
Investigational Site Number 2500006
Investigational Site Number 2500005
Investigational Site Number 8260011
Investigational Site Number 1240005
Investigational Site Number 8260004
Investigational Site Number 8260006
Investigational Site Number 6200001
Investigational Site Number 8400017
Investigational Site Number 1240010
Investigational Site Number 1240001
Investigational Site Number 6200004
Investigational Site Number 5280007
Investigational Site Number 6430003
Investigational Site Number 8400011
Investigational Site Number 8400002
Investigational Site Number 0320002
Investigational Site Number 7240016
Investigational Site Number 3480001
Investigational Site Number 0320001
Investigational Site Number 0360001
Investigational Site Number 3800005
Investigational Site Number 2080002
Investigational Site Number 8400018
Investigational Site Number 1240007
Investigational Site Number 7240011
Investigational Site Number 7050001
Investigational Site Number 7560002
Investigational Site Number 7240010
Investigational Site Number 2330001
Investigational Site Number 8260005
Investigational Site Number 7240014
Investigational Site Number 2760001
Investigational Site Number 3800001
Investigational Site Number 2760004

summary:
Primary Objective:

To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:

To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to:
Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
Cumulative CS (including prednisone) exposure.
To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA.
To measure sarilumab serum concentrations in participants with GCA.
To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

status_simplified: Unknown


acronym: BELINDA

title: Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Bishop MR, Dickinson M, Purtill D, Barba P, Santoro A, Hamad N, Kato K, Sureda A, Greil R, Thieblemont C, Morschhauser F, Janz M, Flinn I, Rabitsch W, Kwong YL, Kersten MJ, Minnema MC, Holte H, Chan EHL, Martinez-Lopez J, Müller AMS, Maziarz RT, McGuirk JP, Bachy E, Le Gouill S, Dreyling M, Harigae H, Bond D, Andreadis C, McSweeney P, Kharfan-Dabaja M, Newsome S, Degtyarev E, Awasthi R, Del Corral C, Andreola G, Masood A, Schuster SJ, Jäger U, Borchmann P, Westin JR. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):629-639. doi: 10.1056/NEJMoa2116596. Epub 2021 Dec 14.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Taiwan
Brazil
Hong Kong
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
Switzerland
United States
France
China
Norway
Belgium
Japan
Germany
Singapore

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: University of California Los Angeles University of California LA

location_facility: Baylor Scott and White Research Institute

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Wayne State University - Karmanos Cancer Institute SC

location_facility: University of Texas MD Anderson Cancer Center MD Anderson Cancer Center

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: Emory University School of Medicine/Winship Cancer Institute SC

summary: This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.


primary_purpose: Prevention

intervention_type: Biological

acronym: Safety and Immunogenicity of V114 in Recipients of Allo-HSCT

title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

location_country:
Brazil
Colombia
Australia
Mexico
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Indiana Blood and Marrow Transplantation ( Site 0001)

location_facility: Hospital Infantil de Mexico Federico Gomez ( Site 0061)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0031)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0107)

location_facility: The Children s Hospital at Westmead ( Site 0191)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0033)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0058)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0187)

location_facility: Hopital Jean Minjoz Besancon ( Site 0085)

location_facility: Austin Health-Austin Hospital ( Site 0038)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0090)

location_facility: Universitaetsklinikum Koeln ( Site 0105)

location_facility: Cleveland Clinic Foundation ( Site 0168)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0075)

location_facility: Instituto Nacional de Pediatria ( Site 0062)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 0051)

location_facility: Instituto Nacional de Cancerologia. ( Site 0060)

location_facility: Baylor College of Medicine - Texas Children's Hospital ( Site 0165)

location_facility: Children's Hospital Colorado ( Site 0166)

location_facility: Servicio de hematologia Universidad Autonoma de Nuevo Leon ( Site 0057)

location_facility: University of Kansas Medical Center ( Site 0007)

location_facility: Karolinska Universitetssjukhuset ( Site 0143)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0050)

location_facility: CHU de Grenoble Hopital Nord ( Site 0083)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0122)

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0121)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0145)

location_facility: AZ Sint Jan Brugge-Oostende ( Site 0118)

location_facility: Cincinnati Children's Hospital Medical Center ( Site 0010)

location_facility: Oregon Health & Science University ( Site 0018)

summary: The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant [allo-HSCT] in participants who do not develop chronic graft-versus-host disease [GVHD]).


acronym: PRECISION

title: Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

lead_sponsor: Idorsia Pharmaceuticals Ltd.

ReferenceCitation: Schlaich MP, Bellet M, Weber MA, Danaietash P, Bakris GL, Flack JM, Dreier RF, Sassi-Sayadi M, Haskell LP, Narkiewicz K, Wang JG; PRECISION investigators. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial. Lancet. 2022 Nov 4. pii: S0140-6736(22)02034-7. doi: 10.1016/S0140-6736(22)02034-7. [Epub ahead of print]

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Czechia
Poland
Russian Federation
Australia
Israel
Canada
Hungary
China
Germany
Denmark
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: KO-MED. Centra Kliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Puławach

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital n.a. E.E. Volosevich"

location_facility: University of Oulu, Medical Research Center

location_facility: University Brescia Department Clinical and Experimental Science

location_facility: Municipal Autonomous Healthcare Institution City Clinical Hospital #6, Gastroenterology Department

location_facility: SCU Medicina Interna e Centro Ipertensione arteriosa. Dipartimento di Scienze Mediche Università di Torino, Aou Citta' Salute E Scienza Torino

location_facility: Federal State Budget Institution "National Medical Research Center n.a. V.A. Almazov" of the Ministry of healthcare of the Russian Federation

location_facility: Azienda Ospedaliero Universitaria PisanA - Department Clinical and Experimental Medicine

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: FN U Sv.Anny Brno, kardiologická klinika

location_facility: The First Affiliated Hospital of Baotou Medical College of Inner Mongolia

location_facility: State Budgetary Educational Institution of Higher Professional Education Smolensk State Medical Academy

location_facility: Municipal non-profit enterprise "Regional Clinical Hospital named after AF Gerbachevsky" of Zhytomyr Regional Council

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

location_facility: International Medical Center "SOGAZ", LLC

location_facility: Universitätsklinikum Erlangen Klinische Forschungsstation (CRC)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Herzzentrum Leipzig Universitätsklinik für Kardiologie

location_facility: Hospital Clínic Universitari de València

location_facility: Hospital Clinico San Carlos - Istituto de Investigacion Sanitaria San Carlos (IdISSC)

location_facility: University Hospitals Cleveland Medical Center - Neurological Institute

location_facility: Yonsei University Wonju Severance Christian Hospital Division of Cardiology - Dept. of Internal Medicine

location_facility: Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

location_facility: SIU School of Medicine Center for Clinical Research

location_facility: Curtin University, Faculty of Health Sciences, School of Public Health

location_facility: State Institution "Institute of Gerontology named after D.F. Chebotarev of National Academy of Medical Sciences of Ukraine"

location_facility: Amarillo Heart Clinical Research Institute, Inc.

location_facility: State Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Regional State Budget Healthcare Institution "Krasnoyarsk Interdistrict Clinical Hospital for Emergency Medical Care n.a. N.S Karpovich", Nephrology Department

location_facility: Klinika Nadciśnienia Tętniczego i Diabetologii

location_facility: National and Kapodistrian University of Athens, School of Medicine Third Department of Medicine, Sotiria Hospital

location_facility: Stephen S. Chow Medicine Professional Corporation

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Federal State Budget Scientific Institution "Federal Research Center Institute of Cytology and Genetics of Siberian Department of Russian Academy of Sciences"

location_facility: Federal State Budget Scientific Institution "Scientific Research Institute for Complex Issues of Cardiovascular Diseases"

location_facility: SBHI of Moscow "City clinical hospital #52" of Moscow healthcare department / city nephrology center

location_facility: Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II w Zamościu

location_facility: Turku University Central Hospital - Turun yliopistollinen keskussairaala Sisätautien klinikka

location_facility: Glasgow Clinical Research Facility (CRF)

location_facility: Hypertension and Nephrology Association PA

location_facility: Scientific Research Institute - Regional Clinical Hospital №1

location_facility: Royal Perth Hospital Unit - The University of Western Australia

location_facility: University Hospitals of Leicester NHS Trust Dept of Chemical Pathology and Metabolic Diseases

location_facility: Municipal Enterprise "Lutsk City Clinical Hospital", Volyn Regional Center for Cardiovascular Pathology

location_facility: State budget healthcare institution of Novosibirsk region "City clinical hospital #34"

location_facility: State Healthcare Institution "Regional Clinical Cardiology Dispensary"

location_facility: State Institution "National Scientific Center "M.D. Strazhesko Institute of Cardiology" of the National Academy of Medical Sciences of Ukraine"

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Regional Hospital Holstebro Department of Medicine University Clinic in Nephrology and Hypertension at Holstebro

location_facility: KO-MED. CentraKliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Lublinie II

location_facility: Federal State Budget Educational Institution of Higher Education "Saratov State Medical University n.a. V.I. Razumovskiy" of the Ministry of Healthcare of the Russian Federation

location_facility: Krajska zdravotni, a.s. - Nemocnice Decin, o.z.

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Jewish General Hospital - Cardiovascular Prevention Center

location_facility: Universitätsklinikum Düsseldorf Klinik für Nephrologie

location_facility: Hypertension Clinic, Internal Medicine, Hospital Clinico, University of Valencia, Valencia

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w

location_facility: St. George Hospital, Dept. Renal Medicine

location_facility: Maastricht University Medical Center, Dept. of Medicine

location_facility: National Medical Research Center for Preventive Medicine

location_facility: University of Alabama at Birmingham Vascular Biology and Hypertension Program

location_facility: Hôpital Saint-André - Service de Cardiologie et Hypertension Artérielle

location_facility: Federal State Budget Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

location_facility: Hospital Virgen del Rocio Departamento de Medicina Interna

location_facility: Federal State Autonomous Institution of Higher Education "Kazan (Volga Region) Federal University"

location_facility: Cardiovascular Research of Northwest Indiana, L.L.C.

location_facility: Clinique Universitaires de Saint Luc, Departement cardio-vasculaires intensives

location_facility: Seoul National University Hospital Division of Cardiology, Department of Internal Medicine

location_facility: TAYS RDI center (Tampere University Hospital,Specialist Internal Medicine, Rare Diseases)

location_facility: Communal Non-profit Enterprise "Vinnytsya regional Clinical Hospital named after. N.I. Pirogov Vinnytsia Regional Council"/ National Pirogov Memorial Medical University, Vinnytsya

location_facility: Federal State Military Educational Institution of Higher Professional Education, Military Medical Academy named for S. M. Kirov of the Ministry of Defense of the Russian Federation

location_facility: Metrolina Internal Medicine/Internal Medicine Research

location_facility: Hôpital Européen Georges Pompidou- Centre d' Investigation Clinique

location_facility: Municipal non-profit enterprise "Clinical Hospital # 8"of Kharkiv City Council

location_facility: Hainan NO.3 Provincial people's Hospital

location_facility: General Hospital Konstantopouleio -Patision

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Horizon Research Group of Opelousas, LLC

location_facility: Hospital Virgen de las Nieves - Internal Medicine Department

location_facility: State Institution "D.F. Chebotarev Institute of Gerontology, National Academy of Medical Science of Ukraine"

location_facility: Municipal Noncommercial Enterprise "Lviv City Clinical Hospital #5"

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Centre Hospitalier Universitaire du Sart-Tilman

location_facility: Azienda Ospedaliera S. Andrea di Roma - Division of Cardiology and of Cardiothoracic and Vascular Science Department -

location_facility: Clinical Research Centre The University of Edinburgh Centre for Cardiovascular Science

location_facility: Aberdeen Royal Infirmary, Clinical Pharmacology Unit

location_facility: Kyiv Municipal Clinical Emergency Hospital

summary: The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.


title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)

summary: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia

ReferenceCitation: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2:CD003233. doi: 10.1002/14651858.CD003233.pub3. Review.

lead_sponsor: ChemoCentryx

location_country:
Poland
United Kingdom
Italy
Australia
New Zealand
Canada
United States
France

location_facility: Presidio Ospedaliero di Montichiari-A.O. Spedali Civili di Brescia

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - II Klinika Nefrologii z Oddzialem Leczenia Nadcisnienia Tetniczego i Pododdzialem Dializoterapii

location_facility: Los Angeles Biomedical Research Institute

location_facility: Salford Royal NHS Foundation Trust Manchester

location_facility: Sunnybrook Health Sciences Centre (Odette Cancer Center)

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnez Centralny Szpital

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Uniwersytecki Szpital Kliniczny Klinika Nefrologii i Medycyny Transplantacyjnej

location_facility: CISSS de la Monteregie-Centre - Hopital Charles LeMoyne

location_facility: University of Texas Health Sciences Center

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Cambridge University - Addenbrooke's Hospital

intervention_type: Other


title: An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

summary: This is an Open-label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed a pegcetacoplan study.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Hong Kong
Serbia
Spain
United Kingdom
Russian Federation
Australia
Canada
Thailand
Korea, Republic of
United States
France
Malaysia
Singapore
Belgium
Japan
Germany
Bulgaria

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Therapeutic hospital of regional clinical hospital #1

location_facility: Essen University Hospital Department of Hematology

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases

location_facility: Hospital Univ. de Gran Canaria Dr.Negrin

location_facility: Investigative Clinical Research of Indiana

location_facility: Hospital Center Chalon Sur Saone William Morey

location_facility: Centre Hospitalier Annecy Genevois - Site Annecy

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Hospital Universitario Politecnico La Fe


title: A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)

summary: Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.

ReferenceCitation: Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortüm KM, Rodríguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.

ReferenceCitation: Prawitz T, Popat R, Suvannasankha A, Sarri G, Hughes R, Wang F, Hogea C, Ferrante SA, Gorsh B, Willson J, Kapetanakis V. DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. Adv Ther. 2021 Nov;38(11):5501-5518. doi: 10.1007/s12325-021-01884-7. Epub 2021 Sep 24.

ReferenceCitation: Nikolaou A, Ambavane A, Shah A, Ma W, Tosh J, Kapetanakis V, Willson J, Wang F, Hogea C, Gorsh B, Gutierrez B, Sapra S, Suvannasankha A, Samyshkin Y. Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis. Expert Rev Hematol. 2021 Dec;14(12):1137-1145. doi: 10.1080/17474086.2021.1970522. Epub 2021 Sep 20.

ReferenceCitation: Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Sborov D, Suvannasankha A, Weisel K, Voorhees PM, Womersley L, Baron J, Piontek T, Lewis E, Opalinska J, Gupta I, Cohen AD. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer. 2021 Nov 15;127(22):4198-4212. doi: 10.1002/cncr.33809. Epub 2021 Jul 27.

ReferenceCitation: Lonial S, Nooka AK, Thulasi P, Badros AZ, Jeng BH, Callander NS, Potter HA, Sborov D, Zaugg BE, Popat R, Degli Esposti S, Byrne J, Opalinska J, Baron J, Piontek T, Gupta I, Dana R, Farooq AV, Colby K, Jakubowiak A. Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM). Blood Cancer J. 2021 May 26;11(5):103. doi: 10.1038/s41408-021-00494-4.

ReferenceCitation: Farooq AV, Degli Esposti S, Popat R, Thulasi P, Lonial S, Nooka AK, Jakubowiak A, Sborov D, Zaugg BE, Badros AZ, Jeng BH, Callander NS, Opalinska J, Baron J, Piontek T, Byrne J, Gupta I, Colby K. Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. Ophthalmol Ther. 2020 Dec;9(4):889-911. doi: 10.1007/s40123-020-00280-8. Epub 2020 Jul 25. Erratum in: Ophthalmol Ther. 2020 Sep 12;:.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Germany


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa

acronym: SHINE

summary: The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

ReferenceCitation: Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horváth B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9.

lead_sponsor: InflaRx GmbH

location_country:
Denmark
Poland
Greece
Netherlands
Canada
United States
France
Germany
Bulgaria

location_facility:
InflaRx Investigational Site
InflaRX Investigational Site


title: An Open Label Phase Ib Dose Finding Study of BI 836880 in Combination With Ezabenlimab to Characterize Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer and in Other Solid Tumors

summary:
This study has 2 parts. The first part was open to adults with advanced non-small cell lung cancer. The second part was open also to adults with other types of advanced cancer of the lung, brain, skin, and liver. After early encouraging results, more people with liver cancer can now take part in the study. The participants get a combination of two medicines called BI 836880 and ezabenlimab.

BI 836880 is a type of an antibody that blocks new blood vessel formation. New blood vessels are needed by the tumour to continue growing. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor).

The purpose of the first part of the study was to find out the highest dose of the BI 836880 that the participants can tolerate in combination with BI 754091. After the best dose of BI 836880 for the combination with ezabenlimab was found, it is used in the second part of the study. The purpose of the second part is to see whether the combination of BI 836880 and BI 754091 is able to make tumours shrink.

The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of BI 836880 and ezabenlimab every 3 weeks. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Taiwan
Hong Kong
Spain
United Kingdom
Russian Federation
Australia
Ukraine
Korea, Republic of
United States
France
Germany

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: "Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, Chemotherapeutic Department with day patient facility".

location_facility: MED POLONIA SP Z O O, Clinical Trials Department,Poznan

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Seoul National University Bundang Hospital

location_facility: Peninsula & South Eastern Oncology Group

location_facility: State Budget Healthcare Institution "Saint-Petersburg clinical research center of specialized types of medical care (oncological)"

location_facility: Mandziuk Slawomir Specialist Medical Practice

location_facility: Medical and Preventive Treatment Inst. Volyn Regional, Lutsk

location_facility: State Budget Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"


title: A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies

summary: This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

lead_sponsor: Eisai Inc.

location_country:
Spain
Italy
United Kingdom
United States
France
Japan
Germany

location_facility: Clinica Neurologica Azienda Ospedaliera di Padova

location_facility: Institut Internacional de Neurociències Aplicades

location_facility: CHRU Nancy- CMRR de lorraine Hôpital de Brabois-Service de Gériatrie

location_facility: New Orleans Center for Clinical Research

location_facility: Manchester Mental Health and Social Care Trust

location_facility: Centre de Recherche Clinique - Viellissement-Cerveau-Fragilite (CRC-VCF), Hopital des Charpennes

location_facility: Pharmax Research of South Florida; Elias Research Associates

location_facility: Parkinsons and Movement Disorders Institute

location_facility: Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital

location_facility: Elias Research Associates (Allied Biomedical Research Institute)

location_facility: New England Institute for Clinical Research

location_facility: Centre d'Investigation Clinique (CIC) Hopitaux universitaires Strasbourg HOPITAL DE HAUTEPIERRE - BATIMENT AX5

location_facility: Memory Assessment and Research Centre, Moorgreen Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Kentucky, Dept of Neurology Sanders Brown Center on Aging

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda


acronym: SEAVUE

title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

lead_sponsor: Janssen Scientific Affairs, LLC

ReferenceCitation: Sands BE, Irving PM, Hoops T, Izanec JL, Gao LL, Gasink C, Greenspan A, Allez M, Danese S, Hanauer SB, Jairath V, Kuehbacher T, Lewis JD, Loftus EV Jr, Mihaly E, Panaccione R, Scherl E, Shchukina OB, Sandborn WJ; SEAVUE Study Group. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11;399(10342):2200-2211. doi: 10.1016/S0140-6736(22)00688-2.

location_country:
Poland
Brazil
Serbia
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Hungary
Korea, Republic of
United States
France
Belgium
Germany
Bulgaria
Czechia

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Oddział Gastroenterologii

location_facility: University of North Carolina at Chapel Hill

location_facility: GU Moscow Regional Research Clinical Institute n.a. M.F.Vla

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Saratoga Schenectady Gastroenterology Associates

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

location_facility: University Hospitals Case Medical Center

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Gastroenterology Associates of Tidewater

location_facility: Center for Advanced Gastroenterology - Main Office

location_facility: Huron Gastroenterology Associates Center for Digestive Care

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Southampton University Hospitals NHS Trust

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: University of Texas at Houston Medical School

location_facility: Gastroenterology Associates of Central Virginia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Western Connecticut Health Network/Danbury Hospital

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Gastroenterology Research of America, LLC

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Seoul National University Bundang Hospital

location_facility: Pennine Acute Hospitals-Fairfield General Hospital

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

location_facility: Mater Hospital Brisbane (Inflammatory Bowel Diseases)

location_facility: Endoskopia Sp. z o.o. z siedzibą w Sopocie

location_facility: Gastro Associates of Fairfield County PC

location_facility: Premier Medical Group Of The Hudson Valley, Pc

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

location_facility: UFRJ-Hospital Universitário Clementino Fraga Filho

location_facility: Diagnostic Consulting Center Mladost - M Varna

summary: The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.


title: A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.

ReferenceCitation: Romero Román A, Campo-Cañaveral de la Cruz JL, Macía I, Escobar Campuzano I, Figueroa Almánzar S, Delgado Roel M, Gálvez Muñoz C, García Fontán EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martínez Téllez E, Partida González C, Jiménez López MF, Jiménez Maestre U, Mongil Poce R, Sánchez Lorente D, Álvarez Kindelán A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Japan
Poland
Slovenia
Austria
Australia
Russian Federation
Israel
Sweden
Brazil
Switzerland
Hungary
China
Germany
Taiwan
Thailand
Korea, Republic of
France

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: Nebraska Methodist Estabrook Cancer Center

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

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

location_facility: NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Hopital d'Instruction des Armees de Begin

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

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Uni Hospital in Lund; Respiratory Medicine & Allergology

location_facility: Hospital Son Llatzer; Servicio de Oncologia

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

location_facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: Klinikum der Univer Regenburg; Klinik und Poliklinik fuer Inn

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

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

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

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

location_facility: Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Uppsala University Hospital; Department of Oncology

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

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

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica


title: Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites

acronym: PRECIOSA

summary: This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

ReferenceCitation: Fernández J, Clària J, Amorós A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Güell M, Nuñez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Árbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Bañares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos García-Pagán J, Pavesi M, Jalan R, Bernardi M, Moreau R, Páez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

lead_sponsor: Grifols Therapeutics LLC

location_country:
Denmark
Poland
Bosnia and Herzegovina
Serbia
Spain
Italy
United Kingdom
Canada
Hungary
United States
France
Belgium
Germany
Bulgaria

location_facility: Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Department for Gastroenterology and Hepatology

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: CHRU de Strasbourg - Hôpital Hautepierre

location_facility: Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika

location_facility: Markhot Ferenc Oktatókórház és Rendelőintézet

location_facility: Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse

location_facility: University Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: 'Health Center Uzice, Internal Diseases Department, Gastroenterology Section

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola

location_facility: University Health Network - Toronto General Hospital

location_facility: Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital Kliniczny im. Barlickiego

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: 'University Clinical Center Nis, Clinic for Gastroenterology and Hepatology

location_facility: Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő, I. Belgyógyászati és Gasztroenterológiai Osztály

location_facility: University Clinical Center Kragujevac, Clinic for Internal Medicine, Gastroenterohepatology Center

location_facility: Royal Free NHS Foundation Trust Hospital

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie, Zakład Endoskopii SIV 31Aug22

location_facility: Clinical Hospital Center "Dr Dragisa Misovic-Dedinje", Clinic for Internal Medicine, Gastroenterology Department

location_facility: Klinika Chorób Wewnętrznych, Diabetologii i Farmakologii Klinicznej, Centralny Szpital Kliniczny

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University Clinical Centre of the Republic Srpska, Clinic for Internal Diseases, Department of gastroenterology, hepatology and toxicology with internal medicine

location_facility: Debreceni Egyetem Klinikai Központ Gasztroenterológiai Klinika

location_facility: Clinical Hospital Center Zvezdara, Clinic for Internal Diseases, Clinical Department for Gastroenterology and Hepatology

location_facility: Pécsi Tudományegyetem, Általános Orvostudományi Kar, Klinikai Központ I. sz. Belgyógyászati Klinika

location_facility: Samodzielny Publiczny Szpital im.Papieza Jana Pawla II

location_facility: Hospital Universitario Politecnico La Fe

location_facility: Ohio State University Wexner Medical Center

location_facility: Azienda Ospedaliero-Universitaria di Modena