To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

FDC tablet (OCA 5 mg + BZF 400 mg SR)

Participants will be administered with FDC tablets once daily.

Trial Locations (51)

1478

Akershus University Hospital, Lørenskog

3000

UZ Leuven, Leuven

4032

DEOEC II. sz. Belgygyszati Klinika, Debrecen

5000

Royal Adelaide Hospital, Adelaide

5042

Flinders Medical Centre, Bedford Park

8036

Hospital ClinicUniversity of Barcelona, Barcelona

8661

University Hopital Santaros klinikos, Vilnius

10016

NYU Langone Health, New York

30100

Research Site SRO, Pilsen

30309

Piedmont Atlanta Hospital, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

33606

Tampa General Medical Group, Tampa

35233

University of Alabama at Birmingham, Birmingham

37604

East Tennessee Research Institute, Johnson City

38138

Gastro One, Germantown

41110

University Hospital of Larissa, Larissa

41944

Kyungpook National University Hospital, Daegu

44106

University Hospitals Cleveland Medical Center, Cleveland

46014

Consorcio Hospital General Universitario, Valencia

50012

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

50090

Tartu University Hospital, Tartu

59000

CHRU de Lille, Lille

70121

Ochsner Clinic Foundation, New Orleans

75012

CHU Paris Est - Hopital Saint Antoine, Paris

75013

Hopital de la Pitie Salpetriere, Paris

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

77030

Houston Methodist Hospital, Houston

78215

American Research Corporation, San Antonio

92118

Southern California Research Center, Coronado

94000

Hopital Henri Mondor, Créteil

722100

Artroscan s.r.o. Gastroenterologicka, Ostrava

9112001

Hadassah Ein-Karem Medical Center - Liver unit, Jerusalem

02215

Beth Israel Deaconess Medical Center, Boston

Unknown

DIM Clinica Privada, Buenos Aires

Hospital Italiano de Buenos Aires, Buenos Aires

Hospital Italiano de La Plata, Buenos Aires

Hospital Universitario Austral, Buenos Aires

Hospital Provincial del Centenario, Santa Fe

University of Alberta Division of Gastroenterology Zeidler Ledcor Centre, Edmonton

Pacific Gastroenterology Associates GI Research Institute, Vancouver

Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna

Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology, Ankara

Ege University, Faculty of Medicine, Gastroenterology, Bornova

Istanbul University, Capa Faculty of Medicine, Gastroenterology, Istanbul

Harran University Hospital, Gastroenterology, Sanliurfa

10 000

Universityl Hospital Dubrava, Zagreb

1005 AZ

Academisch Medisch Centrum, Amsterdam

463-707

Seoul National University Bundang Hospital, Seongnam-si

HU32JZ

Hull University Teaching Hospitals NHS Trust, Hull

NE7 7DN

Institute of Cellular Medicine Newcastle University, Newcastle upon Tyne

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY