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To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Sponsor: Intercept Pharmaceuticals
Summary
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
Official title: A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2024-07-01
Completion Date
2025-10-21
Last Updated
2026-06-08
Healthy Volunteers
No
Conditions
Interventions
FDC tablet (OCA 5 mg + BZF 400 mg SR)
Participants will be administered with FDC tablets once daily.
Locations (51)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Southern California Research Center
Coronado, California, United States
Tampa General Medical Group
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Gastro One
Germantown, Tennessee, United States
East Tennessee Research Institute
Johnson City, Tennessee, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
American Research Corporation
San Antonio, Texas, United States
DIM Clinica Privada
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Italiano de La Plata
Buenos Aires, Argentina
Hospital Universitario Austral
Buenos Aires, Argentina
Hospital Provincial del Centenario
Santa Fe, Argentina
Royal Adelaide Hospital
Adelaide, Australia
Flinders Medical Centre
Bedford Park, Australia
UZ Leuven
Leuven, Belgium
University of Alberta Division of Gastroenterology Zeidler Ledcor Centre
Edmonton, Alberta, Canada
Pacific Gastroenterology Associates GI Research Institute
Vancouver, British Columbia, Canada
Universityl Hospital Dubrava
Zagreb, Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
Artroscan s.r.o. Gastroenterologicka
Ostrava, Czechia
Research Site SRO
Pilsen, Czechia
Tartu University Hospital
Tartu, Estonia
Hopital Henri Mondor
Créteil, France
CHRU de Lille
Lille, France
CHU Paris Est - Hopital Saint Antoine
Paris, France
Hopital de la Pitie Salpetriere
Paris, France
Medizinische Hochschule Hannover
Hanover, Germany
University Hospital of Larissa
Larissa, Greece
DEOEC II. sz. Belgygyszati Klinika
Debrecen, Hungary
Hadassah Ein-Karem Medical Center - Liver unit
Jerusalem, Israel
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy
University Hopital Santaros klinikos
Vilnius, Lithuania
Academisch Medisch Centrum
Amsterdam, Netherlands
Akershus University Hospital
Lørenskog, Norway
Kyungpook National University Hospital
Daegu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Hospital ClinicUniversity of Barcelona
Barcelona, Spain
Consorcio Hospital General Universitario
Valencia, Spain
Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology
Ankara, Turkey (Türkiye)
Ege University, Faculty of Medicine, Gastroenterology
Bornova, Turkey (Türkiye)
Istanbul University, Capa Faculty of Medicine, Gastroenterology
Istanbul, Turkey (Türkiye)
Harran University Hospital, Gastroenterology
Sanliurfa, Turkey (Türkiye)
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