72
Participants
Start Date
October 2, 2019
Primary Completion Date
October 31, 2025
Study Completion Date
October 31, 2025
Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
OCA Placebo
One tablet daily for the remainder of the study
Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
OCA
OCA one tablet will be administered.
Bezafibrate
Bezafibrate one tablet will be administered.
Budai Hepatologiai Centrum (BHC), Budapest
Universitetet i Oslo - Akershus Universitetssykehus (AHUS), Loerenskog
UZ Gasthuisberg, Leuven
DEOEC II. sz. Belgyógyászati Klinika, Debrecen
Royal Adelaide Hospital, Adelaide
Flinders Medical Centre, Bedford Park
Clinical Hospital Dubrava, Zagreb
Zagreb University Hospital Center, Zagreb
Universitatsklinikum Hamburg-Eppendorf UKE, Hamburg
Medizinische Hochschule Hannover, Hanover
Centre Hospitalier Universitaire Grenoble, Grenoble
Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa, Larissa
Kyungpook National University Hospital, Daegu
Consorcio Hospital General Universitario, Valencia
Hospital of Lithuanian University of Health Sciences, Kauno Klinikos, Kaunas
Tartu University Hospital, Tartu
CHRU de Lille, Lille
Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris, Paris
Hadassah Ein-Karem Medical Center - Liver unit, Jerusalem
Hôpital Henri Mondor, Créteil
Tel Aviv Surasky Medical Center, Tel Aviv
Hepato-Gastroenterologie HK, s.r.o., Hradec Králové
Artroscan s.r.o., Gastroenterologicka ambulance, Ostrava
Research Site s.r.o., Pilsen
CHU Paris Est - Hopital Saint Antoine, Paris
Vlinius University, Vilnius
Academisch Medisch Centrum, Amsterdam
Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej, Warsaw
Pusan National University Hospital, Busan
Fundacio Clinic Per La Recerca Biomedica, Barcelona
Hull University Teaching Hospitals NHS Trust, Hull
Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne
John Radcliffe Hospital, Oxford
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY