acronym: MK-4482 Ph 2/3 Study in Non-Hospitalized Adults with COVID-19

title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.

ReferenceCitation: Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Aug;175(8):1126-1134. doi: 10.7326/M22-0729. Epub 2022 Jun 7.

ReferenceCitation: Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martín-Quirós A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Philippines
Japan
Poland
Russian Federation
Argentina
Israel
Mexico
Sweden
Egypt
Brazil
Canada
Guatemala
Germany
Taiwan
France
Chile
Colombia

location_facility: McGill University Health Centre ( Site 0204)

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)

location_facility: Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)

location_facility: Fundacion Arturo Lopez Perez ( Site 0305)

location_facility: Jadestone Clinical Research, LLC ( Site 2502)

location_facility: University of Nebraska Medical Center ( Site 2414)

location_facility: Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)

location_facility: Advanced Medical Research, LLC ( Site 1864)

location_facility: Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)

location_facility: Fred Hutchinson Cancer Center ( Site 1829)

location_facility: Smorodintsev Research Institute of Influenza ( Site 1129)

location_facility: Midway Immunology and Research Center ( Site 1837)

location_facility: Hopital Bichat Claude Bernard ( Site 0503)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0604)

location_facility: SPb SBHI City outpatient clinic 112 ( Site 1128)

location_facility: Clinical Research Partners, LLC. ( Site 2503)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)

location_facility: Chiba Aoba Municipal Hospital ( Site 0702)

location_facility: Strategic Medical System LLC ( Site 1114)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0700)

location_facility: ARTEM. State Holding Company ( Site 1618)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1302)

location_facility: Medical Research Institute LLC ( Site 1116)

location_facility: Centre Hospitalier de Tourcoing ( Site 0502)

location_facility: National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)

location_facility: Fundacion Santa Fe de Bogota ( Site 0412)

location_facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)

location_facility: Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

location_facility: Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)

location_facility: Indago Research & Health Center, Inc ( Site 1809)

location_facility: Emerson Clinical Research Institute ( Site 1828)

location_facility: Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

location_facility: Clinical Projects Research Centre ( Site 1215)

location_facility: Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)

location_facility: NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

location_facility: Hospital Universitario La Paz ( Site 1300)

location_facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)

location_facility: Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1303)

location_facility: University of New Mexico, Health Sciences Center ( Site 1819)

location_facility: The Crofoot Research Center, Inc. ( Site 1812)

location_facility: IRCCS Ospedale Policlinico San Martino ( Site 0603)

location_facility: Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)

location_facility: CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

location_facility: Köhler & Milstein Research S.A. de C.V. ( Site 0809)

location_facility: Groupe Hospitalier Pellegrin ( Site 0511)

location_facility: Clinical Research Chile SpA ( Site 0308)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1105)

location_facility: Swedish Medical Center First Hill ( Site 1807)

location_facility: Medical Center Health Clinic ( Site 1623)

location_facility: Universitaetsklinikum Essen ( Site 2305)

location_facility: Carbon Health Technologies Inc ( Site 2505)

location_facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: SPb SBHI City outpatient clinic 4 ( Site 1131)

location_facility: Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

location_facility: Instituto de Infectologia Emilio Ribas ( Site 0153)

location_facility: PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)

location_facility: Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)

location_facility: Saint Hope Foundation, Inc. ( Site 1830)

location_facility: Clinica Universidad de los Andes ( Site 0302)

location_facility: C.H.U. de Toulouse Hopital Purpan ( Site 0501)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1400)

location_facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)

location_facility: Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)

location_facility: Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)

location_facility: Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)

location_facility: Hospital Universitario Infanta Leonor ( Site 1310)

location_facility: St.Petersburg Outpatient Clinic No. 109 ( Site 1119)

location_facility: Fundacion Hospital Alcorcon de Madrid ( Site 1314)

location_facility: FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)

location_facility: Royal Free London NHS Foundation Trust ( Site 1700)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0402)

location_facility: Limpopo Clinical Research Initiative ( Site 1227)

location_facility: Clinical Research Institute S.C. ( Site 0813)

location_facility: Advanced Research For Health Improvement LLC ( Site 1813)

location_facility: Advanced Research For Health Improvement LLC ( Site 1816)

location_facility: MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

location_facility: Lung Center of the Philippines ( Site 0902)

location_facility: ICH Study Center GmbH & Co.KG ( Site 2306)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

location_facility: Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0811)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)

location_facility: Enhancing Care Foundation-DICRS ( Site 1216)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0150)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2100)

location_facility: AOU Policlinico Paolo Giaccone ( Site 0609)

location_facility: ICARO Investigaciones en Medicina ( Site 0812)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

location_facility: ClinSmart Sweden AB.Uppsala ( Site 1402)

location_facility: Limited liability company "Scientific research center Eco-safety" ( Site 1117)

location_facility: Limited Liability Company Medical center Healthy Happy ( Site 1625)

location_facility: National Taiwan University Hospital ( Site 3100)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0415)

location_facility: Hamilton Medical Research Group ( Site 0207)

location_facility: City Hospital No.33 of Leninsky ( Site 1127)

location_facility: Amici Clinical Research LLC ( Site 2507)

location_facility: Central Scientific Research Institute of Epidemiology ( Site 1104)

location_facility: Universitaetsklinikum Frankfurt ( Site 2302)

location_facility: Ruane Clinical Research Group, Inc. ( Site 2406)

location_facility: Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)

location_facility: CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)

location_facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

location_facility: Smolensk State Medical University ( Site 1110)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

location_facility: National Center for allergies and chest ( Site 3320)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

location_facility: Medical College Of Wisconsin ( Site 2510)

location_facility: Right To Care Research - Esizayo ( Site 1229)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)

location_facility: Mzansi Ethical Research Centre ( Site 1225)

location_facility: MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)

location_facility: Centro de Investigacion Clinica UC CICUC ( Site 0309)

location_facility: University Health Network - Toronto General Hospital ( Site 0201)

location_facility: Quirino Memorial Medical Center ( Site 0903)

location_facility: Accellacare South London Quality Research Centre ( Site 1709)

location_facility: Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)

location_facility: Michigan Center of Medical Research ( Site 2500)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

location_facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

location_facility: Wits Baragwanath Clinical Trial Site ( Site 1214)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29


type: EudraCT Number

title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

acronym: SANCTUARY

summary: The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

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: No

lead_sponsor: Alexion Pharmaceuticals

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Sweden
Korea, Republic of
United States
France
Singapore
Germany

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

acronym: RESOLVE-IT

summary: The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Genfit

location_country:
Spain
Italy
United Kingdom
United States
Romania
South Africa
Belgium
Czechia
Portugal
Russian Federation
Australia
Argentina
Puerto Rico
Turkey
Mexico
Sweden
Canada
Switzerland
Germany
Denmark
Finland
France
Chile
Colombia
Netherlands

location_facility: Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)

location_facility: University of California, San Diego Airway Research and Clinical Trials Center

location_facility: The University of Chicago Medical Center

location_facility: Baylor All Saints Medical Center - Baylor Research Institute

location_facility: Caparra Internal Medicine Research Center

location_facility: Instituto de Investigaciones Clinicas San Nicolas SRL

location_facility: New York-Presbyterian Hospital - Columbia University Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Henry Ford Health System, Division of Gastroenterology & Hepatology

location_facility: Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: Hospital Universitario San Vicente de Paul Fundación

location_facility: Military medical academy n. a. S.M. Kirov

location_facility: Weill Medical College of Cornell University

location_facility: St George's University Hospitals NHS Foundation Trust - St George's Hospital

location_facility: Walter Reed National Military Medical Center

location_facility: University of California, Davis Medical Center

location_facility: University of Miami - Miller School of Medicine

location_facility: Saint Louis University School of Medicine

location_facility: Digestive Health Specialists of the Southeast

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

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Northwestern Memorial Hospital - Arkes Family Pavilion

location_facility: Yale University School of Medicine, Section of Digestive Diseases

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

location_facility: Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Centro de Investigación y Prevención Cardiovascular SA (CIPREC)

location_facility: Centro Hospitalar de São João, EPE - Hospital de São João

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara

location_facility: Centre Hospitalier de Wallonie Picardie (CHWAPI)

location_facility: Gastroenterology Consultants of San Antonio

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Gastroenterologie am Bayerischen Platz/ Gastro-Studien

location_facility: Universitätsklinikum Frankfurt - Goethe Universität

location_facility: Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi

location_facility: Fundación Cardio Infantil - Instituto de Cardiología

location_facility: University Hospitals Birmingham NHS foundation Trust

location_facility: Medical University of South Carolina (MUSC)

location_facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos

location_facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

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

location_facility: Bon Secours Liver Institute of Virginia - Newport News

location_facility: Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO

location_facility: Sutter West Bay Hospitals dba California Pacific Medical Center

location_facility: The University of Arizona College of Medicine Liver Research Institute

location_facility: FSBRI "Federal Research Center of nutrition and biotechnology

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

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Florida Digestive Health Specialists, LLP

location_facility: Rutgers, Robert Wood Johnson Medical School

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary

location_facility: St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31

location_facility: Loma Linda University Medical Center - Transplantation Insitute

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

location_facility: Bart Health NHS Trust- Royal London Hospital

location_facility: Frimley Park Hospital NHS Foundation Trust

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Banner University Medical Center Phoenix

location_facility: University of California, San Francisco, Medical Center at Parnassus

location_facility: University Hospitals Cleveland Medical Center

location_facility: Gastrointestinal Biosciences Clinical Trials LLC

location_facility: St. Luke's Liver Transplant & Specialist

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Inova Fairfax Medical Campus - Center for Liver Disease

location_facility: University of Miami - Schiff Center for Liver Diseases

location_facility: New York University Langone Medical Center

location_facility: Atlantic Gastroenterology Associates, LLC

location_facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

location_facility: University of Kentucky Chandler Medical Center

location_facility: Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health

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

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Mississippi Medical Center

location_facility: University of California, San Francisco, Fresno Community Regional Medical Center

location_facility: Fundacion Hospitalaria San Vicente de Paul

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Veterans Affairs Greater Los Angeles Healthcare System

location_facility: Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)

location_facility: Centro De Hepatologia Ciudad de La Plata

location_facility: University of Louisville Medical / Dental Complex

location_facility: University of Calgary, Cumming School of Medicine

location_facility: Bon Secours Liver Institute of Virginia - Richmond

location_facility: Kaiser Permanente Springfield Medical Center

location_facility: Gastrointestinal Associates & Endoscopy Center

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: M. F. Vladimirsky - Clinical Research Institution of Moscow Region

location_facility: SC Cabinet Particular Policlinic Algomed SRL

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

location_facility: Centro Hospita de Tras-os-Montes e Alto Douro, EPE

location_facility: I. M. Sechenov - First Moscow State Medical University

location_facility: University of Cincinnati Physicians Company , LLC

location_facility: Kaiser Permanente Shady Grove Medical Center

location_facility: Centro de Investigación Clínica del Pacífico, S.A de C.V.

location_facility: Marmara Üniversitesi Eğitim ve Araştırma Hastanesi

intervention_type: Drug

status_simplified: Unknown


title: A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

acronym: PANTHER

summary:
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.

Data will be collected both retrospectively and prospectively.

study_type: Observational

time_perspective: Other

lead_sponsor: Vascutek Ltd.

location_country:
Netherlands
Canada
Hungary
United States
France
Belgium
Germany

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of South Florida - Tampa General

location_facility: Ludwig-Maximilian Universität (LMU) Klinikum

location_facility: Universitätsmedizin Mainz (University Hospital Mainz)

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

intervention_type: Device


title: A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed

acronym: SOLAR

summary: This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

status: Active, not recruiting

ipd_sharing: Yes

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

lead_sponsor: ViiV Healthcare

location_country:
Spain
Ireland
Austria
Australia
Italy
Canada
Netherlands
Switzerland
United Kingdom
United States
France
Belgium
Japan
Germany


title: Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease

acronym: Entyvio PASS

summary: The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

status: Completed

time_perspective: Prospective

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Portugal
Slovenia
Austria
Israel
Norway
Sweden
Canada
Switzerland
Germany
Denmark
Greece
Ireland
Estonia
France
Netherlands

location_facility: Gastroenterology Center of Connecticut P.C.

location_facility: The Royal Wolverhampton Hospitals Nhs Trust - New Cross Hospital

location_facility: Chu de Clermont Ferrand - Hopital Estaing

location_facility: Universitaetsspital Bern - Inselspital - Universitaetsklinik Fuer Viszerale Chirurgie Und Medizin (Uvcm) - Klinik Und Poliklinik Fuer Gastroenterologie

location_facility: Oslo Univeristy Hospital Ulleval Hospital

location_facility: General and University Hospital of Western Athens 'Attiko'

location_facility: Centre Hospitalier Universitaire (Chu) de Nice - Hopital L'Archet 2 - Pole Digestif

location_facility: Azienda Ospedaliera Per Lemergenza Cannizzaro

location_facility: Kantonsspital St. Gallen - Gastroenterologie

location_facility: Technische Universitaet Dresden - Universitaetklinikum Carl Gustav Carus - Medizinische Klinik Und Poliklinik I

location_facility: Pinderfields Hospital - Mid Yorkshire Hospital Trust

location_facility: Charite Campus Virchow Klinikum - Medizinische Klinik Mit Schwerpunkt Hepatologie Und Gastroenterologie

location_facility: Fondazione Irccs Ca' Granda Osp Magg Policlinico

location_facility: University of Toronto - St. Michaels Hospital

location_facility: University and General Hospital of Alexandroupoli

location_facility: King'S College Hospital (Kch) Nhs Foundation Trust

location_facility: Medizinische Versorgungszentrum Portal 10

location_facility: Rambam Health Care Campus (Rhcc) - Institute of Gastroenterology

location_facility: Gastroenterologische Gemeinschaftspraxis Dr. Felten

location_facility: Medizinisches Versorgungszentrum (Mvz) Dachau

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Cbf) - Medizinische Klinik I

location_facility: Medizinischen Universitat Wien - Allgemeines Krankenhaus (Akh) - Universitaetsklinik Fuer Innere Medizin Iii

location_facility: Centre Hospitalo Universitaire (Chu) - Hopital Saint-Antoine

location_facility: Centre Hospitalier Universitaire (Chu) de Caen - Service D'Hepatogastroenterologie

location_facility: Wake Forest University School of Medicine

location_facility: University Hospital of Ioannina - Division of Gastroenterology

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Gemeinschaftspraxis - Endoskopiezentrum M. Hasenstein

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum Hochhaus Lindenhofspital

location_facility: Agaplesion Markus Krankenhaus, Medizinische Klinik 1

location_facility: St. Josef Krankenhaus Essen-Werden / Abteilung Fur Gastroenterologie

location_facility: Chu Saint Pierre - Service de Gastroenterologie

location_facility: Az Maria Middelares - Gastro-Enterologie

location_facility: Ospedale Morgagni Pierantoni Forli U.O. Gastroenterologia Ed Endoscopia

location_facility: University Hospital Southampton Nhs Foundation Trust

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, Epe

location_facility: Nevill Hall Hospital - Aneurin Bevan Health Board

location_facility: Tel Aviv University - Rabin Medical Center - Beilinson Hospital

location_facility: Emory University Hospital, the Emory Clinic

location_facility: The Shrewsbury and Telford Hospital Nhs Trust - Royal Shrewsbury Hospital

location_facility: Centre Hospitalier Chretien (Chc) - Clinique Saint-Joseph (Hopital St-Joseph) - Gastro-Enterologie

location_facility: University of Sheffield - Sheffield Teaching Hospitals Nhs Foundation Trust - Royal Hallamshire Hospital (Rhh)

location_facility: Universitatsklinikum Erlangen Medizinische Klinik I - Studien Ambulanz Ced

location_facility: Assaf Harofeh Medical Center (Ahmc) - Institute of Gastroenterology

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Centre Hospitalier Universitaire (Chu) de Rouen

location_facility: Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot

location_facility: Service Gastro-Enterologie Hopital Nord - Chu de Saint Etienne

location_facility: Universitatsklinik Und Poliklinik Fur Innere Medizin I

location_facility: Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona

location_facility: Universitaire Ziekenhuizen (Uz) Leuven - Gasthuisberg

location_facility: Boston University Moakley Building Center For Digestive Disorders

location_facility: Hopital Du Haut Leveque - Service D'Hepato-Gastro-Enterologie Et Nutritution, Unite de Soin Normalise

location_facility: Complexo H. Pontevedra-Hospital de Montecelo

location_facility: The North West London Hospitals Nhs Trust (Nwlh) - St Mark'S Hospital

location_facility: A.O. Guido Salvini Di Garbagnate Milanese

location_facility: Nyu Langone Long Island Clinical Research Associates

location_facility: General Hospital of Athens 'Evangelismos'

location_facility: Centre Hospitalier de Wallonie Picardie, Site Notre Dame

location_facility: Nhs Foundation Trust - Homerton University Hospital (Huh)

location_facility: Western Sussex Hospitals Nhs Trust - Worthing Hospital

location_facility: Consultants in Gastroenterology - Columbia

location_facility: Derby Hospitals Nhs Foundation Trust - Royal Derby Hospital (Derby City General Hospital)

location_facility: Universitat Leipzig, Medizinische Fakultat

location_facility: Hopital Rangueil - Service de Gastroenterologie

location_facility: St. Panteleimon General Hospital of Nikaia

location_facility: Krankenhaus Martha-Maria Halle Dolau Ggmbii, Klinik Fur Innere Medizin I

location_facility: University Hospitals Coventry and Warwickshire Nhs Trust - University Hospital (Walsgrave Hospital)

location_facility: Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik

location_facility: Ordination Dr. Thomas Haas Darmpraxis Salzburg

location_facility: Universitaetsmedizin Mainz, I.Med.Klinik, Geb.605, Eg, Zi.0240

location_facility: University of Iowa Hospitals and Clinics

location_facility: Praxis Fur Gastroenterologie Am Bayerischen Platz

location_facility: Blackpool Victoria Hospital (Bvh) - Gastroenterology Department

location_facility: South Bay Gastroenterology Medical Group

location_facility: Illinois Gastroenterology Groupllc Northwest Gastroenterologists

location_facility: University and General Hospital of Heraklion

location_facility: Ziekenhuis Oost Limburg - Gastro-Enterologie

location_facility: Chu Hopital Nord, Marseille - Service D'Hepato-Gastro-Enterologie

location_facility: Ch Valenciennes - Hopital Jean Bernard - Service Maladies de L'Appareil Digestif Et de La Nutrition

location_facility: Gastroenterologische Gemeinschaftspraxis - Stade

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

location_facility: The University of Nottingham - Nottingham Digestive Diseases Centre (Nddc) (Wolfson Digestive Diseases Centre)

location_facility: Nhs Trust - Weston Area Health - Weston General Hospital

location_facility: St. Marien Krankenhauses - Medizinischen Klinik I

location_facility: Middlesex Gastroenterology Associates, Llc

location_facility: Spedali Civili Gastroenterology Unit University of Brescia

location_facility: Az Groeninge - Campus Kennedylaan - Gastro-Enterologie

location_facility: Gastroenterologische Fachpraxis Am Germania Campus

location_facility: Hospices Civils de Lyon (Hcl) - Centre Hospitalier Lyon-Sud - Hepatogastroenterologie

location_facility: Universitatsklinikum Magdeburg A. O. R. - Klinik Fur Gastroenterologie

location_facility: Chu Amiens Picardie - Service Hepato-Gastro-Enterologie

status_simplified: Completed


title: On Demand vs Continuous Treatment of Endoscopy Negative Subjects With Gastroesophageal Reflux Disease (GERD) With Esomeprazole 20-mg Once Daily Over a 6 Months Long Term Treatment Phase. An Open, Randomised, Multicenter Study. NEED.

acronym: NEED

summary: The purpose of this study is to compare on demand with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief.

ReferenceType: derived

ReferenceCitation: Bayerdörffer E, Bigard MA, Weiss W, Mearin F, Rodrigo L, Dominguez Muñoz JE, Grundling H, Persson T, Svedberg LE, Keeling N, Eklund S. Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease. BMC Gastroenterol. 2016 Apr 14;16:48. doi: 10.1186/s12876-016-0448-x.

lead_sponsor: AstraZeneca

location_country:
Spain
Austria
France
South Africa
Germany

location_facility: Gastroenterology Clinic, E23, Groote Schuur Hospital Observatory

location_facility: Gastroenterology Clinic, Milpark Hospital

location_facility: Gastroenterology Unit, Room C78, Tygerberg Hospital

location_facility: Gastroenterology Clinic, G73, Department of Internal Medicine, Universitas Hospital

location_facility: Gastroenterology Clinic, Parorama Medi-Clinic

location_facility: Gastroenterology Clinic, Parklands Medical Centre

location_facility: Carl Gustav Carus der Tecnischen Universität

location_facility: Gastroenterology Unit, Chris Hani Baragwanath Hospital


title: Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry

acronym: XARENO

summary:
The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).

The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.

lead_sponsor: GWT-TUD GmbH

location_country: Austria Switzerland France Belgium Germany

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen

location_facility: Praxis Dr. med. Christoph Axthelm & Kollegen

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

location_facility: Centre Hospitalier Chrétien (CHC) St Joseph

location_facility: Gemeinschaftspraxis Wittwer, Bargemann, Baar

location_facility: Gemeinschaftspraxis Scheuermann & Persicke

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Centre Hospitalier de Wallonie Picarde (Chwapi)

location_facility: Marienkrankenhaus Klinikum St. Elisabeth

location_facility: Kardiologische Praxis Dr. med. Ayham Al Zoebi

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin

location_facility: Zentrum für Prävention und Rehabilitation

location_facility: CHI Toulon La Seyne sur mer - Hopital Sainte Musse

location_facility: Gemeinschaftspraxis Dr. med. Sybille Jänsch

location_facility: St. Joseph Krankenhaus Berlin-Tempelhof GmbH

location_facility: Gemeinschaftspraxis im Altstadtcarree, Kardiologie

location_facility: Gemeinschaftspraxis Kellner und Ehrhardt

location_facility: Studienzentrum Dr. med. Karl-Friedrich Appel

location_facility: CHG de Chartres-Hôpital Général Louis Pasteur

location_facility: CH Argenteuil Centre Hospitalier Victor Dupouy

location_facility: Centre Hospitalier Universiatire du SART-TILMAN


title: A Randomized Parallel Group Phase III Trial of OSE2101 as 2nd or 3rd Line Compared With Standard Treatment (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Advanced Non-Small-Cell Lung Cancer With Progressive Disease After Last Treatment With Immune Checkpoint Inhibitors (ICI). (OSE2101C301)

acronym: ATALANTE 1

summary: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment after failure of immune checkpoint-inhibitor regimens.

ReferenceType: background

ReferenceCitation: Barve M, Bender J, Senzer N, Cunningham C, Greco FA, McCune D, Steis R, Khong H, Richards D, Stephenson J, Ganesa P, Nemunaitis J, Ishioka G, Pappen B, Nemunaitis M, Morse M, Mills B, Maples PB, Sherman J, Nemunaitis JJ. Induction of immune responses and clinical efficacy in a phase II trial of IDM-2101, a 10-epitope cytotoxic T-lymphocyte vaccine, in metastatic non-small-cell lung cancer. J Clin Oncol. 2008 Sep 20;26(27):4418-25. doi: 10.1200/JCO.2008.16.6462.

ReferenceCitation: Beebe M, Qin M, Moi M, Wu S, Heiati H, Walker L, Newman M, Fikes J, Ishioka GY. Formulation and characterization of a ten-peptide single-vial vaccine, EP-2101, designed to induce cytotoxic T-lymphocyte responses for cancer immunotherapy. Hum Vaccin. 2008 May-Jun;4(3):210-8. Epub 2010 May 11.

ReferenceCitation: Nemunaitis J, Cunningham, C ,Bender, J, Ishioka, G, Maples, P, Pappen, B, Stephenson, J, Morse, M, Mills, B, Greco, A, McCune, D, Steis, R, Nugent, F, Khong, HT, Richards, D. Phase II trial of a 10-epitope CTL vaccine, IDM-2101, in metastatic NSCLC patients: Induction of immune responses and clinical efficacy. International Society for Biological Therapy of Cancer 2007, p 891-2.

lead_sponsor: OSE Immunotherapeutics

location_country:
Poland
Spain
Italy
United Kingdom
Hungary
United States
France
Israel
Germany
Czechia

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T)

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Universitario Puerta de Hierro Majadahonda Servicio de Oncología Médica Consultas externas, 2ª planta

location_facility: UOC di Oncologia Medica, Policlinico Universitario Campus Biomedico

location_facility: Országos Korányi TBC és Pulmonológiai Intézet XI Tüdőbelosztály

location_facility: Azienda USL 2 Lucca - Dipartimento Oncologico

location_facility: "Complejo Hospitalario Universitario A Coruna (CHUAC)"

location_facility: UOC di Oncologia Medica Policlinico Universitario Campus Biomedico

location_facility: Mazowieckie Centrum Leczenia chorób Płuc i Gruźlicy

location_facility: Universitätsklinikum Tübingen Medizinische Klinik II

location_facility: Klinik für Innere Medizin II Hospital Martha-Maria Halle-Dölau gGmbH

location_facility: Klinika Onkologii i Radioterapii , Uniwersyteckie Centrum Kliniczne

location_facility: Wojewódzki Szpital Zespolony , Oddział Chemioterapii Nowotworów

location_facility: Krankenhaus Mehrheit - Kliniken der Stadt Köln - Lungenklinik

location_facility: Klinik für Innere Medizin II Universitätsklinikum Ulm

location_facility: Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika

location_facility: East Valley Hematology and Oncology medical Group

location_facility: Országos Korányi TBC és Pulmonológiai Intézet XIV Tüdőbelosztály

location_facility: Unità Operativa di Oncologia dell'Ospedale Vito Fazzi di Lecce, Piazza Muratore

location_facility: U.O Oncologia ed Ematologia, Ospedale Santa Maria delle Croci

location_facility: Hospital Universitario La Paz Servicio de Oncología Médica

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorháza I Tüdőosztály

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont II szamu telephely

location_facility: U.O.C. Pneumologia a indirizzo oncologico, Presidio Ospedaliero Monaldi - Azienda Ospedaliera dei Colli - Via Leonardo Bianchi


title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection

lead_sponsor: Gilead Sciences

source: euctr

publications_result: Jacobson IM, Asselah T, Nahass R, Bhandari BR, Tran A, Hyland RH, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study [Abstract LB-12]. Hepatology AASLD Abstracts 2016;64 (6 (suppl)):1126A.

ReferenceType: result

ReferenceCitation: Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Bräu N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

location_country:
United Kingdom
Australia
New Zealand
Canada
Puerto Rico
United States
France
Germany

summary: The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.


title: A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer Who Have Experienced Disease Progression With Prior Anti-PD-1 Therapy

summary: This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

lead_sponsor: ISA Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
France
United States
Israel
Belgium
Germany
Czechia

location_facility: The University of Texas M. D. Anderson Cancer Center

location_facility: CHU La Timone - La Timone Children's Hospital

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Institute of Cancer Research and Treatment of Candiolo

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University Hospital Cologne, Department of Otorhinolaryngology (ENT)

location_facility: Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Oncology

location_facility: Saint Andre Hospital, Department of Oncology

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University Hospital Giessen and Marburg GmbH

location_facility: University Hospital Motol, Clinic of Oncology

location_facility: Jean Godinot Institute, Cancer Research Center

location_facility: Nordwest Hospital GmbH, Clinic of Hematology and Oncology

location_facility: Leon Berard Center, Department of Medical Oncology

location_facility: European Institute of Oncology (IEO), IRCCS, Department of Otolaryngology and Facial Cervix Surgery


intervention_type: Biological

title: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Identifier

type: Registry Identifier

ReferenceCitation: Jabbour SK, Cho BC, Bria E, Kato T, Bhosle J, Gainor JF, Reguart N, Wang L, Morgensztern D, Shentu Y, Kim SJ, Souza F, Reck M. Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Sep;23(6):e342-e346. doi: 10.1016/j.cllc.2022.04.003. Epub 2022 Apr 29.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Romania
Japan
Czechia
Poland
Russian Federation
Turkey
Mexico
Norway
Canada
Hungary
China
Germany
Latvia
Estonia
Thailand
Korea, Republic of
France
Chile

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0100)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2805)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)

location_facility: Kansai Medical University Hospital ( Site 3103)

location_facility: Spitalul Universitar de Urgenta Bucuresti ( Site 2508)

location_facility: Christie NHS Foundation Trust ( Site 1409)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0811)

location_facility: North Estonia Medical Centre Foundation ( Site 1601)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 1100)

location_facility: Franciscan St. Francis Health ( Site 0031)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3204)

location_facility: The Cancer Institute Hospital of JFCR ( Site 3107)

location_facility: Niigata Cancer Center Hospital ( Site 3109)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0066)

location_facility: Clinique de l'Europe-Service de pneumologie ( Site 0816)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)

location_facility: St. Bernards Medical Center ( Site 0089)

location_facility: Akershus Universitetssykehus HF ( Site 1106)

location_facility: Torrance Memorial Physician Network / Cancer Center ( Site 0093)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0602)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2208)

location_facility: Peking University Shenzhen Hospital ( Site 3216)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)

location_facility: Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)

location_facility: Long Beach Memorial Medical Center ( Site 0006)

location_facility: Duke University Medical Center ( Site 0050)

location_facility: Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 1401)

location_facility: Medipol Universite Hastanesi ( Site 2003)

location_facility: Masarykuv onkologicky ustav ( Site 2206)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 1410)

location_facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 0902)

location_facility: SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: West China Hospital of Sichuan University ( Site 3202)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2101)

location_facility: Riga East Clinical University Hospital ( Site 1500)

location_facility: Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)

location_facility: Piedmont Hematology-Oncology Associates ( Site 0080)

location_facility: Centro Oncologico Antofagasta ( Site 0204)

location_facility: Shanghai Pulmonary Hospital ( Site 3203)

location_facility: Azienda Ospedaliera Vito Fazzi ( Site 1003)

location_facility: Seoul National University Bundang Hospital ( Site 2801)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0901)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)

location_facility: Policlinico Agostino Gemelli ( Site 1002)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)

location_facility: Severance Hospital Yonsei University Health System ( Site 2808)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 1909)

location_facility: Osaka International Cancer Institute ( Site 3106)

location_facility: Medical institute named after Berezin Sergey ( Site 1906)

location_facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)

location_facility: Gyeongsang National University Hospital ( Site 2804)

location_facility: Massachusetts General Hospital ( Site 0038)

location_facility: Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)

location_facility: Johannes Wesling Klinikum Minden ( Site 0908)

location_facility: H.R.U Málaga - Hospital General ( Site 1206)

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

location_facility: Daping Hospital,Third Military Medical University ( Site 3235)

location_facility: Keimyung University Dongsan Hospital ( Site 2807)

location_facility: S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)

location_facility: Ege University Medical Faculty ( Site 2005)

location_facility: Second Xiangya Hospital of Central-South University ( Site 3227)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0806)

location_facility: Chungbuk National University Hospital ( Site 2802)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)

location_facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)

location_facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)

location_facility: Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0606)

location_facility: Peking Union Medical College Hospital ( Site 3201)

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

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0088)

location_facility: Hospital Universitario La Fe ( Site 1203)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)

location_facility: Instituto Nacional de Cancerologia ( Site 0502)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 3108)

location_facility: Vestre Viken HF Drammen Sykehus ( Site 1101)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0013)

location_facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1000)

location_facility: LLC Ukrainian Center of Tomotherapy ( Site 2105)

location_facility: Fakultni nemocnice v Motole ( Site 2210)

location_facility: Hospital Universitario Virgen Macarena ( Site 1205)

location_facility: Royal Marsden Hospital (Sutton) ( Site 1407)

location_facility: Hospital Universitario Quiron Madrid ( Site 1200)

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

location_facility: Kyiv City Clinical Oncology Center ( Site 2100)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 3002)

location_facility: Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 2306)

location_facility: St. Joseph Heritage Healthcare Local Lab ( Site 0011)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)

location_facility: Southampton General Hospital ( Site 1400)

location_facility: Pauls Stradins Clinical University Hospital ( Site 1501)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)

location_facility: Azienda Ospedaliera Umberto I- Torrette ( Site 1009)

location_facility: Krajska nemocnice Liberec, a.s. ( Site 2209)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3110)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)

location_facility: Hospital Clinic de Barcelona ( Site 1204)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)

location_facility: Zhongshan Hospital Fudan University ( Site 3220)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1001)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)

location_facility: McGill University Health Center - Research Institute ( Site 0114)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)

location_facility: Institutul Regional de Oncologie Iasi ( Site 2505)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0054)

location_facility: Washington University Siteman Cancer Center ( Site 0046)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 3219)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)

location_facility: Juntendo University Hospital ( Site 3111)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 3104)

location_facility: Fujian Provincial Cancer Hospital ( Site 3226)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0094)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 0003)

location_facility: VA St. Louis Health Care System ( Site 0047)

location_facility: Mid Florida Hematology and Oncology Center ( Site 0022)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0202)

location_facility: Zentralklinik Bad Berka GmbH ( Site 0905)

location_facility: Orlando Health, UF Health Cancer Center Inc ( Site 0092)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)

location_facility: University College Hospital NHS Foundation Trust ( Site 1403)

location_facility: Xiangya Hospital of Central South University ( Site 3637)

location_facility: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)

location_facility: The Second Affiliated Hospital of Nanchang University ( Site 3206)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 3100)

location_facility: CLIMERS Clinical Medical Research ( Site 0506)

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis

summary: The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

ReferenceCitation: Corte TJ, Lancaster L, Swigris JJ, Maher TM, Goldin JG, Palmer SM, Suda T, Ogura T, Minnich A, Zhan X, Tirucherai GS, Elpers B, Xiao H, Watanabe H, Smith RA, Charles ED, Fischer A. Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA(1)) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial lung disease (PF-ILD). BMJ Open Respir Res. 2021 Dec;8(1). pii: e001026. doi: 10.1136/bmjresp-2021-001026.

ReferenceCitation: Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA(1)) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.

lead_sponsor: Bristol-Myers Squibb

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Mexico
Argentina
Canada
Korea, Republic of
United States
Chile
China
France
Belgium
Israel
Germany
Japan

location_facility: Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik V

location_facility: University of Virginia Health System-Division of Pulmonary and Critical Care Medicine

location_facility: Central Florida Pulmonary Group-Research

location_facility: University of Kansas Medical Center-Division of Pulmonary and Critical Care Medicine

location_facility: Steward St. Elizabeth's Clinical Laboratory

location_facility: Austin Health-Respiratory and Sleep Medicine

location_facility: Royal Adelaide Hospital-Respiratory Clinical Trials Unit

location_facility: University of Alabama at Birmingham-Division of Pulmonary, Allergy & Critical Care Med

location_facility: Washington University School Of Medicine

location_facility: Johns Hopkins Bayview Medical Center-Johns Hopkins Asthma & Allergy Center

location_facility: University of Florida College of Medicine-Pulmonary, Critical Care and Sleep medicine

location_facility: Westmead Hospital-Department of Respiratory and Sleep Medicine

location_facility: University of Colorado Anschutz Medical Campus-Department of Medicine

location_facility: The Lung Research Center-The Lung Research Center

location_facility: Royal Prince Alfred Hospital-Department of Respiratory Medicine

location_facility: Gallipoli Medical Research Foundation-GMRF CTU

location_facility: University of Cincinnati Medical Center-Division of Pulmonary, Critical Care and Sleep Medicine

location_facility: Fiona Stanley Hospital-Advanced Lung Disease Unit


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

summary:
The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

ReferenceCitation: Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528.

ReferenceCitation: Sands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Frédéric Colombel J, Rossiter G, Usiskin K, Ather S, Zhan X, D'Haens G. Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study. Am J Gastroenterol. 2020 May;115(5):738-745. doi: 10.14309/ajg.0000000000000493.

lead_sponsor: Celgene

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Malaysia
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Estonia
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University of North Carolina at Chapel Hill

location_facility: CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI

location_facility: CHA Bundang Medical Center CHA University

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: Azienda Ospedaliera Universitaria Policlinico G Martino

location_facility: Mercy Clinic East Communities d/b/a Mercy Health Research

location_facility: Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

location_facility: Gastroenterology Associates of Tidewater

location_facility: London Health Science Center U. Hospital

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Clinsante S.C. Osrodek Badan Klinicznych

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: McMaster University Health Sciences Center

location_facility: Yeditepe University Medical School Hospital

location_facility: Hospital Clinic I Provincial de Barcelona

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

location_facility: Asheville Gastroenterology Associates, PA

location_facility: SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Seoul National University Bundang Hospital

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: The Methodist Hospital Research Institute

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Henry Ford Medical Center - New Center One

location_facility: Southwest Gastroenterology Associates PC

location_facility: KH der Barmherzigen Brüder St.Veit an der Glan

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

location_facility: RSHI State Novosibirsk Regional Clinical Hospital

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow

location_facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: University of Pennsylvania School of Medicine

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: General Hospital of Heraklion Benizeleio Pananeio

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.

location_facility: Florida Medical Research - Southeastern Integrated Medical

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno

location_facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

location_facility: Northwestern University-Feinberg School of Medicine

location_facility: Seconda Universita Degli Studi Di Napoli

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov

location_facility: Ordination Dr. Thomas Haas Darmpraxis Salzburg

location_facility: Stavanger Unviversitetssjukehus Helse Stavanger HF

location_facility: University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung

location_facility: McGill University Health Centre Glen Site Royal Victoria Hospital

location_facility: University of Southern California Medical Center

location_facility: Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen

location_facility: General Hospital of Nikaea Piraeus Ag. Panteleimon

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

location_facility: Indywidualna Praktyka Lekarska Maciej Zymla

location_facility: The Feinstein Institute for Medical Research PRIME

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: University General Hospital of Alexandroupolis

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: University Hospitals Case Medical Center

location_facility: Johns Hopkins University School of Medicine

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Nemocnica s poliklinikou sv Barbory Roznava a s

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Private Educational Institution of Higher Education Medical university REAVIZ

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: University of Texas Health Science Center at Houston

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF

location_facility: Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Texas Digestive Disease Consultants Dallas

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

location_facility: Clinexpert Egeszsegugyi Szolg es Ker Kft

location_facility: Zentrum fuer HIV und Hepatogastroenterologie GmbH

location_facility: Oklahoma University Health Sciences Center

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona

location_facility: Groupement Hospitalier Sud Hopital Bicetre

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

location_facility: Gastroenterology Associates of Western Michigan PLC

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: Ternopil City Communal Emergency Medical Care Hospital

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La

location_facility: Lviv Regional Clinical Hospital D Halytskyi Lviv NMU

location_facility: University General Hospital of Heraklion

location_facility: North Shore Long Island Jewish Health System

location_facility: New York - Presbyterian/Weill Cornell Medical Center

location_facility: RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

location_facility: University of California at San Francisco

location_facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie

location_facility: Nottingham University Hospitals Queens Medical Centre

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: Medical Research Center of Connecticut LLC

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways

location_facility: Anticancer Hospital of Thessaloniki THEAGENIO

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

location_facility: University of Wisconsin Hospital and Clinics

location_facility: SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

location_facility: Spitalul Clinic Judetean de Urgente Sf. Spiridon

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre de sante et de services sociaux Champlain Charles Le Moyne

location_facility: University of Washington School of Medicine

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Communal Institution City Policlinic #20 Cabinet of Gastroenterology

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Wake Forest University Baptist Medical Center

location_facility: SBHI of NN region RCH of NN n.a. N.A.Semashko

location_facility: SBHI of Yaroslavl Region Clinical Hospital 8

location_facility: Via Christi Research a division of Via Christi Hospitals Wichita Inc

location_facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

location_facility: Soukroma Gastroenterologicka ambulance a endoskopie


title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

acronym: REGENERATE

summary: The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

ReferenceCitation: Rinella ME, Dufour JF, Anstee QM, Goodman Z, Younossi Z, Harrison SA, Loomba R, Sanyal AJ, Bonacci M, Trylesinski A, Natha M, Shringarpure R, Granston T, Venugopal A, Ratziu V. Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study. J Hepatol. 2022 Mar;76(3):536-548. doi: 10.1016/j.jhep.2021.10.029. Epub 2021 Nov 15.

ReferenceCitation: Younossi ZM, Stepanova M, Nader F, Loomba R, Anstee QM, Ratziu V, Harrison S, Sanyal AJ, Schattenberg JM, Barritt AS, Noureddin M, Bonacci M, Cawkwell G, Wong B, Rinella M; RandomizEd Global Phase 3 Study to Evaluate the Impact on NASH with FibRosis of Obeticholic Acid TreatmEnt (REGENERATE) Study Investigators. Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2050-2058.e12. doi: 10.1016/j.cgh.2021.07.020. Epub 2021 Jul 15.

ReferenceCitation: Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5. Erratum in: Lancet. 2020 Aug 1;396(10247):312. Erratum in: Lancet. 2021 Jun 19;397(10292):2336.

ReferenceCitation: Ratziu V, Sanyal AJ, Loomba R, Rinella M, Harrison S, Anstee QM, Goodman Z, Bedossa P, MacConell L, Shringarpure R, Shah A, Younossi Z. REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis. Contemp Clin Trials. 2019 Sep;84:105803. doi: 10.1016/j.cct.2019.06.017. Epub 2019 Jun 29.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Poland
Portugal
Austria
Australia
Puerto Rico
Israel
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
New Zealand
Finland
France

location_facility: AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Indiana University Health University Hospital

location_facility: Southern Therapy and Advanced Research, LLC

location_facility: California Pacific Medical Center (CPMC)

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego

location_facility: Service d'Hepato-Gastroenterologie CHR Orleans - La Source

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institute for Liver and Digestive Health

location_facility: Gastroenterology Consultants of San Antonio

location_facility: Hospital General y Universitario de Alicante

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Massachusetts Medical School

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: University Hospital Bristol NHS Foundation Trust

location_facility: Asheville Gastroenterology Associates, PA

location_facility: The Queen's Medical Center - Liver Center

location_facility: Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: University Hospitals Coventry & Warwickshire

location_facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

location_facility: UZ Leuven Campus Gathuisberg Hepatology Department

location_facility: University of California Davis Medical Center

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: University Hosptial Cologne Clinics for Gastroenterology and Hepatology

location_facility: Azienda Ospedaliera Universitaria Policlinico

location_facility: The University of Chicago Medical Center

location_facility: Hospital (Universitario) Marqués de Valdecilla

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

location_facility: Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie

location_facility: Walter Reed National Military Medical Center

location_facility: Soroka Medical Center Division of Internal Medicine

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Baylor Scott & White All Saints Medical Center

location_facility: Charite Universitätsmedizin Campus Virchow

location_facility: Saint Louis University Gastroenterology & Hepatology

location_facility: New York University (NYU) Langone Medical Center

location_facility: Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary

location_facility: Veteran Affairs Great Los Angeles Healthcare System

location_facility: Florida Digestive Health Specialist Research Institute

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz

location_facility: University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: The University of Vermont Medical Center - Smith 2

location_facility: Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III

location_facility: Norfolk and Norwich University Hospitals

location_facility: University of Louisville Medical, Clinical Trials Unit

location_facility: University of Kentucky Chandler Medical Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: CHI Health Alegent Creighton Clinic Gastroenterology

location_facility: Methodist Healthcare, University Hospital

location_facility: South Florida Center of Gastroenterology, P.A.

location_facility: The Research Institute of the McGill University Health Centre

location_facility: Rambam Medical Center Center for Liver diseases

location_facility: Carolinas Center for Liver Disease/Carolinas HeatlhCare System

location_facility: University Hospitals Case Medical Center

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: Prisma Health- Upstate Gastroenterology and Liver Center

location_facility: Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1

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

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: Hospital del Mar Gastroenterology Department

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition

location_facility: Institute for Liver Health DBA Arizona Liver Health

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: University of Wisconsin Hospital & Clinics

location_facility: London Health Sciences Centre University Hospital

location_facility: CHU de Nancy - Hôpital de Brabois adultes

location_facility: Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Gastroenterology Department Hull Royal Infirmary

location_facility: The Alfred Hospital, Department of Gastroenterology

location_facility: Digestive Health Specialists of the Southeast

location_facility: Hôpital Henri Mondor - Service d'hépatologie

location_facility: Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie

location_facility: Universitätsklinik für Innere Medizin I Innsbruck

location_facility: Royal Adelaide Hospital Gastroenterology and Hepatology Dept.

location_facility: Hospital (Universitario) Virgen de la Victoria

location_facility: Hospital Saint Antoine Department of Hepatology

location_facility: Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo

location_facility: Consorcio Hospital General Universitario

location_facility: St. Josef-Hospital, Ruhr University Bochum

location_facility: Rutgers University New Jersey Medical School

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Nottingham Digestive Diseases and Biomedical Research Unit

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Baylor College of Medicine Ben Taub General Hospital

location_facility: Indianapolis Gastroenterology & Hepatology

location_facility: University of Colorado Denver and Hospital

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Washington University School of Medicine - Gastroenterology

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hospital Universitario Fundación Alcorcon

location_facility: Huron Gastroenterology Associates/Center for Digestive Care

location_facility: University of North Carolina at Chapel Hill, School of Medicine

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik

location_facility: University Clinic of Gastroenterology & Hepatology