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Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Sponsor: Intercept Pharmaceuticals
Summary
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
Official title: A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2019-10-02
Completion Date
2025-10-14
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (33)
Flinders Medical Centre
Bedford Park, Perth, Australia
Royal Adelaide Hospital
Adelaide, Australia
UZ Gasthuisberg
Leuven, Belgium
Clinical Hospital Dubrava
Zagreb, Croatia
Zagreb University Hospital Center
Zagreb, Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
Artroscan s.r.o., Gastroenterologicka ambulance
Ostrava, Czechia
Research Site s.r.o.
Pilsen, Czechia
Tartu University Hospital
Tartu, Estonia
Hôpital Henri Mondor
Créteil, France
Centre Hospitalier Universitaire Grenoble
Grenoble, France
CHRU de Lille
Lille, France
Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris
Paris, France
CHU Paris Est - Hopital Saint Antoine
Paris, France
Universitatsklinikum Hamburg-Eppendorf UKE
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa
Larissa, Greece
Budai Hepatologiai Centrum (BHC)
Budapest, Hungary
DEOEC II. sz. Belgyógyászati Klinika
Debrecen, Hungary
Hadassah Ein-Karem Medical Center - Liver unit
Jerusalem, Israel
Tel Aviv Surasky Medical Center
Tel Aviv, Israel
Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
Kaunas, Lithuania
Vlinius University
Vilnius, Lithuania
Academisch Medisch Centrum
Amsterdam, Netherlands
Universitetet i Oslo - Akershus Universitetssykehus (AHUS)
Loerenskog, Norway
Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej
Warsaw, Poland
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Fundacio Clinic Per La Recerca Biomedica
Barcelona, Spain
Consorcio Hospital General Universitario
Valencia, Spain
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Institute of Cellular Medicine, Newcastle University
Newcastle upon Tyne, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom