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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 determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
Official title: A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2022-03-21
Completion Date
2025-09-01
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
Bezafibrate 100 mg
One tablet of bezafibrate 100 mg IR once daily
Bezafibrate 200 mg
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
Obeticholic Acid 5 mg
One tablet of obeticholic acid 5 mg tablet once daily.
Obeticholic Acid placebo
One tablet of obeticholic acid placebo tablet once daily
Bezafibrate Placebo
One tablet of bezafibrate placebo tablet once daily
Locations (26)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado
Coronado, California, United States
Facey Medical Group
Mission Hills, California, United States
Schiff Center for Liver Diseases / University of Miami
Miami, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center Harvard Liver Research Center
Boston, Massachusetts, United States
NYU Langone Medical Center
New York, New York, United States
Wake Endoscopy Center
Raleigh, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Gastro One
Cordova, Tennessee, United States
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, United States
Methodist Clinical Research Institute (CRI)
Dallas, Texas, United States
Houston Methodist Cancer Center
Houston, Texas, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Hospital Italiano La Plata
La Plata, Buenos Aires, Argentina
DIM Clinical Privada
Ramos Mejía, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
The Northern Alberta Clinical Trials and Research Centre
Edmonton, Alberta, Canada
Pacific Gastroenterology Associates
Vancouver, British Columbia, Canada
University of Montreal
Montreal, Quebec, Canada
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy