Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

October 2, 2019

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Obeticholic acid

5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily

DRUG

Bezafibrate 200 MG

200 mg IR tablet of Bezafibrate once daily for the remainder of the study

DRUG

OCA Placebo

One tablet daily for the remainder of the study

DRUG

Bezafibrate 200 mg Placebo

One tablet daily for the remainder of the study

DRUG

Bezafibrate 400 MG

400 mg SR tablet of Bezafibrate once daily for the remainder of the study

DRUG

Bezafibrate 400 mg Placebo

One tablet daily for the remainder of the study

DRUG

OCA

OCA one tablet will be administered.

DRUG

Bezafibrate

Bezafibrate one tablet will be administered.

Trial Locations (33)

1111

Budai Hepatologiai Centrum (BHC), Budapest

1478

Universitetet i Oslo - Akershus Universitetssykehus (AHUS), Loerenskog

3000

UZ Gasthuisberg, Leuven

4032

DEOEC II. sz. Belgyógyászati Klinika, Debrecen

5000

Royal Adelaide Hospital, Adelaide

5042

Flinders Medical Centre, Bedford Park

10000

Clinical Hospital Dubrava, Zagreb

Zagreb University Hospital Center, Zagreb

20246

Universitatsklinikum Hamburg-Eppendorf UKE, Hamburg

30625

Medizinische Hochschule Hannover, Hanover

38043

Centre Hospitalier Universitaire Grenoble, Grenoble

41110

Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa, Larissa

41944

Kyungpook National University Hospital, Daegu

46010

Consorcio Hospital General Universitario, Valencia

50161

Hospital of Lithuanian University of Health Sciences, Kauno Klinikos, Kaunas

51014

Tartu University Hospital, Tartu

59000

CHRU de Lille, Lille

75651

Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris, Paris

91120

Hadassah Ein-Karem Medical Center - Liver unit, Jerusalem

940000

Hôpital Henri Mondor, Créteil

6423906

Tel Aviv Surasky Medical Center, Tel Aviv

500 12

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

722 00

Artroscan s.r.o., Gastroenterologicka ambulance, Ostrava

301 00

Research Site s.r.o., Pilsen

Paris 12

CHU Paris Est - Hopital Saint Antoine, Paris

08661

Vlinius University, Vilnius

1105 AZ

Academisch Medisch Centrum, Amsterdam

02-781

Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej, Warsaw

602-739

Pusan National University Hospital, Busan

08036

Fundacio Clinic Per La Recerca Biomedica, Barcelona

HU3 2JZ

Hull University Teaching Hospitals NHS Trust, Hull

NE2 4HH

Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY