A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

July 9, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Elafibranor

Round and orange film coated tablet of 80 mg.

OTHER

Placebo

Round and orange film coated tablet of placebo

Trial Locations (60)

11030

Northwell Health Center for Liver Disease and Transplantation, Manhasset

28277

Charlotte Gastroenterology & Hepatology, PLLC, Charlotte

28304

Coastal Research Institute, Fayetteville

33614

International Center for Research, Tampa

38018

Gastroenterology Center of the Midsouth, Cordova

48109

University of Michigan Health System, Ann Arbor

48197

Huron Gastroenterology Associates - Center for Digestive Care, Ypsilanti

71291

Delta Research Partners, LLC, West Monroe

75203

Methodist Transplant Physicians, Dallas

78215

American Research Corporation at The Texas Liver Institute, San Antonio

American Research Corporation, San Antonio

80113

South Denver Gastroenterology,P.C., Englewood

80120

Rocky Mountain Gastroenterology, Littleton

80135

Peak Gastroenterology Associates, Colorado Springs

87109

Southwest Gastroenterology Associates, PC (SWGA), Albuquerque

90005

Topgraphy Health, Inc., Los Angeles

92118

Southern California Research Center, Coronado

94305

Stanford University Medical Center, Stanford

95616

University of California, Davis, Sacramento

98105

Velocity Liver Institute NW, Seattle

Unknown

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

Artroscan, Ostrava

Research Site s.r.o., Pilsen

Institute for Clinical and Experimental Medicine - IKEM, Prague

Clinique Pasteur, Toulouse

Universitatsklinikum Heidelberg, Heidelberg

Gastroenterologsiche Studiengesellschaft Herne, Hemer

EUGASTRO GmbH, Leipzig

Universitaetsklinikum Muenster, Münster

Ospedale Policlinico San Martino - IRCCS, Genova

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

Azienda Ospedaliero Universitaria Pisana, Pisa

IRCCS Istituto clinico humanitas - Humanitas Mirasole spa, Rozzano

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

FutureMeds Warszawa Centrum, Warsaw

Cluj County Clinical Emergency Hospital, Cluj-Napoca

Gastromedica Srl, Iași

Korea University Ansan Hospital, Ansan-si

Keimyung University Dongsan Hospital, Daegu

Kyungpook National University Hospital (KNUH), Daegu

Pusan National University Hospital (PNUH), Pusan

CHA Bundang Medical Center, CHA University, Seongnam-si

Seoul National University Bundang Hospital (SNUBH), Seongnam-si

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital, Yonsei University Health System, Seoul

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

Hospital Clinic i Provincial de Barcelona, Barcelona

Hospital Universitario Vall d'Hebron, Barcelona

Hospital Universitario La Paz, Madrid

Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda

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

Hospital Universitario Miguel Servet, Zaragoza

Aberdeen Royal Infirmary NHS Grampian Grampian Health Board, Aberdeen

Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation, Bradford

Frimley Park Hospital - Frimley Health NHS Foundation Trust, Frimley

Queen Elizabeth University Hospital - Greater Glasgow Health Board, Glasgow

Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust, Hull

Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust, London

King's College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY