A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

August 31, 2023

Primary Completion Date

May 31, 2029

Study Completion Date

May 31, 2029

Conditions
Primary Biliary Cholangitis (PBC)
Interventions
DRUG

Elafibranor

Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which elafibranor 80 mg tablet will be administered once daily

OTHER

Matched 80 mg placebo

Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which matching placebo tablet will be administered once daily

Trial Locations (158)

10016

RECRUITING

NYU Langone Gastroenterology and Hepatology Associates, New York

15213

RECRUITING

University of Pittsburgh, Pittsburgh

20007

WITHDRAWN

Medstar Georgetown Transplant Institute University Hospital (MGUH), Columbia

22201

RECRUITING

Texas Clinical Research Institute, Arlington

22903

RECRUITING

University of Virginia Medical Center, Charlottesville

23226

RECRUITING

Bon Secours St. Mary's Hospital of Richmond, Inc, Richmond

23298

NOT_YET_RECRUITING

Virginia Commonwealth University Medical Center - West Hospital, Richmond

29425

RECRUITING

Medical University of South Carolina, Charleston

33136

RECRUITING

University Of Miami School Of Medicine, Center For Liver Diseases, Miami

33614

RECRUITING

International Center for Research, Tampa

38138

RECRUITING

Gastroenterology Center of the Midsouth, Cordova

46026

RECRUITING

Hospital Universitario y Politecnico La Fe, Valencia

48109

RECRUITING

University of Michigan Health System, Ann Arbor

48197

RECRUITING

Huron Gastroenterology Associates - Center for Digestive Care, Ypsilanti

55130

TERMINATED

Arkansas Diagnostic Center, PA, Little Rock

60612

WITHDRAWN

Rush University Medical Center - University Cardiovascular Surgeons, Dallas

66160

NOT_YET_RECRUITING

University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic, Kansas City

71103

RECRUITING

Louisiana Research Center, LLC, Shreveport

75203

RECRUITING

Liver Center of Texas, Dallas

RECRUITING

Methodist Transplant Physicians, Dallas

75390

RECRUITING

University of Texas Southwestern Medical Center at Dallas, Dallas

76104

WITHDRAWN

Baylor Scott & White All Saints Medical Center - Forth Worth, Fort Worth

76710

RECRUITING

Impact Research Tx, Waco

77030

RECRUITING

Liver Associates of Texas, Houston

77584

RECRUITING

Houston Methodist Cancer Center, Houston

77904

WITHDRAWN

Gastro health & Nutrition, Katy

78015

RECRUITING

American Research Corporation at The Texas Liver Institute, San Antonio

78757

RECRUITING

American Research Corporation, Austin

80045

RECRUITING

University of Colorado, Aurora

80113

RECRUITING

South Denver Gastroenterology, P.C., Englewood

80120

RECRUITING

Rocky Mountain Gastroenterology, Littleton

80829

RECRUITING

Peak Gastroenterology Associates, Colorado Springs

85641

RECRUITING

Arizona Liver Health, Tucson

87109

RECRUITING

Southwest Gastroenterology Associates, PC (SWGA), Albuquerque

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

90067

RECRUITING

GastroIntestinal BioSciences, Los Angeles

90404

WITHDRAWN

University of California Los Angeles, Los Angeles

92118

RECRUITING

Southern California Research Center, Coronado

95817

NOT_YET_RECRUITING

University of California Davis Medical Center, Sacramento

98105

RECRUITING

Velocity Clinical Research at Liver Institute Northwest, Seattle

700111

RECRUITING

Gastromedica Srl, Iași

Unknown

NOT_YET_RECRUITING

DIM Centro Medico, Buenos Aires

RECRUITING

Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L, Buenos Aires

RECRUITING

Hospital Britanico de Buenos Aires, Buenos Aires

RECRUITING

Hospital Italiano de Buenos Aires, Buenos Aires

RECRUITING

Centro Medico Colon, Córdoba

RECRUITING

Hospital Espanol de Mendoza, Mendoza

RECRUITING

Hospital Universitario Austral, Pilar

NOT_YET_RECRUITING

Hospital El Cruce, San Juan Bautista

RECRUITING

Sunshine Coast University Hospital, Birtinya

RECRUITING

Footscray Hospital, Western Health, Footscray

RECRUITING

Nepean Clinical School, Kingswood

RECRUITING

Monash University - Monash Health -Monash Medical Centre, Melbourne

RECRUITING

St George Hospital, Sydney

RECRUITING

Westmead Hospital, Westmead

RECRUITING

Universitair Ziekenhuis Antwerpen, Edegem

RECRUITING

Ziekenhuis Oost-Limburg, Genk

RECRUITING

Gent University Hospital, Ghent

RECRUITING

Algemeen Ziekenhuis Delta, Roeselare

RECRUITING

NUPEC Cardio, Belo Horizonte

RECRUITING

Universidade Federal de Goias, Goiânia

RECRUITING

Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre

RECRUITING

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

RECRUITING

Hospital de Base - Centro Integrado de Pesquisa ( CIP ), São Paulo

RECRUITING

Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB), São Paulo

RECRUITING

Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia

RECRUITING

Tokuda Hospital, Dept. of Internal Medicine, Sofia

RECRUITING

University Hospital City Clinic Cancer Center, Sofia

RECRUITING

University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR), Edmonton

RECRUITING

University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI), Toronto

RECRUITING

Universidad De Los Andes, Las Condes

RECRUITING

Centro de Estudios Clinicos e Investigaciones Medicas (CECIM), Santiago

RECRUITING

Enroll SpA, Santiago

RECRUITING

Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago

NOT_YET_RECRUITING

University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile), Santiago

RECRUITING

Centro Medico Cedid - Centro de Diagnostico Digestivo, Viña del Mar

RECRUITING

Hepato-Gastroenterologie HK, s.r.o., Hradec Králové

NOT_YET_RECRUITING

Krajska Nemocnice Liberec, Liberec

RECRUITING

Artroscan, Ostrava

RECRUITING

Research Site s.r.o., Pilsen

RECRUITING

Institute for Clinical and Experimental Medicine - IKEM, Prague

RECRUITING

Bispebjerg Hospital, Copenhagen

RECRUITING

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez, Lille

RECRUITING

Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse, Lyon

WITHDRAWN

Hopital Saint Joseph - Marseille, Marseille

RECRUITING

CHU de Nice, Hopital de l'Archet, Nice

WITHDRAWN

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere), Paris

RECRUITING

CHU Poitiers, Poitiers

RECRUITING

Clinique Pasteur, Toulouse

RECRUITING

Hopital Paul-Brousse - APHP, Villejuif

RECRUITING

Agios Savvas Regional Cancer Hospital, Athens

RECRUITING

General Hospital of Athens Laiko, Athens

RECRUITING

General Oncological Hospital of Kifisia Oi Agioi Anargyroi, Athens

RECRUITING

GeneIppokratio General Hospital of Thessaloniki, Thessaloniki

RECRUITING

Central Hospital of Northern Pest - Military Hospital, Budapest

RECRUITING

Kenezy County Hospital, Debrecen

RECRUITING

Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika, Szeged

RECRUITING

Hadassah University Hospital (HUH) - Ein-Kerem, Jerusalem

RECRUITING

Shaare Zedek Medical Center, Jerusalem

RECRUITING

Galilee Medical Center, Nahariya

RECRUITING

Azienda Ospedaliero Universitaria Modena, Modena

RECRUITING

Ospedale San Gerardo, Monza

RECRUITING

Azienda Ospedaliero Universitaria Federico II di Napoli, Naples

RECRUITING

Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia, Padua

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

WITHDRAWN

Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

RECRUITING

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

NOT_YET_RECRUITING

Centro de Investigacion Medico Biologica y Terapia Avanzada, Jalisco

NOT_YET_RECRUITING

Centro de Investigacion y Gastroenterologia SC, Mexico City

NOT_YET_RECRUITING

Medical Care & Research, Yucatán

RECRUITING

Canterbury District Health Board, Christchurch

RECRUITING

Waikato Hospital, Hamilton

RECRUITING

NZOZ Twoje Zdrowie EL Sp. z o.o., Elblag

RECRUITING

Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego, Katowice

RECRUITING

Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds, Krakow

WITHDRAWN

Szpital Uniwersytecki w Krakowie, Krakow

NOT_YET_RECRUITING

Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds, Małogoskie

RECRUITING

Centrum Medyczne Medyk Sp. z o.o. Sp. K., Rzeszów

WITHDRAWN

Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera, Sosnowiec

RECRUITING

FutureMeds Warszawa Centrum, Warsaw

RECRUITING

FutureMeds sp. z o. o, Wroclaw

RECRUITING

Nzoz Centrum BadanKlinicznych, Wroclaw

RECRUITING

PlanetMed Sp. z o.o., Wroclaw

RECRUITING

Centrul Pentru Studiul Metabolismului, Bucharest

RECRUITING

Sana S.R.L, Bucharest

RECRUITING

Spital Clinic Dr I Cantacuzino, Bucharest

RECRUITING

Cluj County Clinical Emergency Hospital, Cluj-Napoca

RECRUITING

Pusan National University Hospital (PNUH), Busan

RECRUITING

Keimyung University Dongsan Hospital, Daegu

RECRUITING

The Catholic University of Korea Daejeon St.Mary's Hospital, Daejeon

RECRUITING

Inje University Ilsan Paik Hospital, Goyang-si

RECRUITING

Korea University Ansan Hospital, Gyeonggi-do

RECRUITING

Inha University Hospital, Incheon

RECRUITING

Kyungpook National University Hospital (KNUH), Junggu

RECRUITING

CHA Bundang Medical Center, CHA University, Seongnam-si

RECRUITING

Chung-Ang University Hospital, Seoul

WITHDRAWN

Hallym University Kangnam Sacred Heart Hospital, Seoul

RECRUITING

Korea University Guro Hospital, Seoul

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul National University Bundang Hospital (SNUBH), Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

RECRUITING

The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

RECRUITING

The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Uijeongbu-si

RECRUITING

Hospital Clinic i Provincial de Barcelona, Barcelona

RECRUITING

Hospital Universitario Vall d'Hebron, Barcelona

RECRUITING

Clinica Universidad Navarra-Sede Madrid, Madrid

RECRUITING

Hospital General Universitario Gregorio Maranon (HGUGM), Madrid

NOT_YET_RECRUITING

Hospital Universitario La Paz, Madrid

RECRUITING

Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

WITHDRAWN

Hospital De Montecelo, Pontevedra

RECRUITING

Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli, Sabadell

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

RECRUITING

Hospital Universitario Rio Hortega, Valladolid

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY