To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

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

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).

Study Overview

• Status: Terminated
• Conditions: Primary Biliary Cholangitis
• Intervention / Treatment: Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina
    • Hospital Universitario Austral
  • Buenos Aires, Argentina
    • DIM Clinica Privada
  • Buenos Aires, Argentina
    • Hospital Italiano de La Plata
  • Santa Fe, Argentina
    • Hospital Provincial del Centenario
• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Bedford Park, Australia, 5042
    • Flinders Medical Centre
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta Division of Gastroenterology Zeidler Ledcor Centre
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Pacific Gastroenterology Associates GI Research Institute
• Croatia
  • Zagreb, Croatia, 10 000
    • Universityl Hospital Dubrava
• Czechia
  • Hradec Králové, Czechia, 50012
    • Hepato-gastroenterologie HK, s.r.o.
  • Ostrava, Czechia, 722100
    • Artroscan s.r.o. Gastroenterologicka
  • Pilsen, Czechia, 30100
    • Research Site SRO
• Estonia
  • Tartu, Estonia, 50090
    • Tartu University Hospital
• France
  • Créteil, France, 94000
    • Hopital Henri Mondor
  • Lille, France, 59000
    • CHRU de Lille
  • Paris, France, 75013
    • Hopital de la Pitie Salpetriere
  • Paris, France, 75012
    • CHU Paris Est - Hopital Saint Antoine
• Germany
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
• Greece
  • Larissa, Greece, 41110
    • University Hospital Of Larissa
• Hungary
  • Debrecen, Hungary, 4032
    • DEOEC II. sz. Belgygyszati Klinika
• Israel
  • Jerusalem, Israel, 9112001
    • Hadassah Ein-Karem Medical Center - Liver unit
• Italy
  • Bologna, Italy
    • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
• Lithuania
  • Vilnius, Lithuania, 8661
    • University Hopital Santaros klinikos
• Netherlands
  • Amsterdam, Netherlands, 1005 AZ
    • Academisch Medisch Centrum
• Norway
  • Lørenskog, Norway, 1478
    • Akershus University Hospital
• South Korea
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Seongnam-si, South Korea, 463-707
    • Seoul National University Bundang Hospital
• Spain
  • Barcelona, Spain, 8036
    • Hospital ClinicUniversity of Barcelona
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology
  • Bornova, Turkey (Türkiye)
    • Ege University, Faculty of Medicine, Gastroenterology
  • Istanbul, Turkey (Türkiye)
    • Istanbul University, Capa Faculty of Medicine, Gastroenterology
  • Sanliurfa, Turkey (Türkiye)
    • Harran University Hospital, Gastroenterology
• United Kingdom
  • Hull, United Kingdom, HU32JZ
    • Hull University Teaching Hospitals NHS Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Institute of Cellular Medicine Newcastle University
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Coronado, California, United States, 92118
      • Southern California Research Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Medical Group
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Atlanta Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee Research Institute
  • Texas
    • Dallas, Texas, United States, 75203
      • The Liver Institute at Methodist Dallas Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • San Antonio, Texas, United States, 78215
      • American Research Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).

Exclusion Criteria:

• History or presence of other concomitant liver diseases
• Clinical complications of PBC
• History or presence of hepatic decompensating events
• Current or history of gallbladder disease
• If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCA 5 mg + BZF 400 mg SR; Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.	Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR); Participants will be administered with FDC tablets once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants reporting adverse events (AE) and serious adverse event (SAE)	Up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score	The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10-centimeter (cm) line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	Up to 60 months
Number of participants reporting all-cause mortality		Up to 60 months
Number of participants with Adjudicated Liver Related Clinical Outcomes - Liver transplant		Up to 60 months
Number of participants with Adjudicated Liver Related Clinical Outcomes - Progression to hepatic decompensation		Up to 60 months
Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score ≥15	MELD is a scoring system for assessing the severity of chronic liver disease and to assess prognosis and suitability for liver transplantation. It uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores 10-19=6.0% mortality; Score 9 or less=1.9% mortality. Higher scores indicated greater disease severity. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status.	Up to 60 months

Collaborators and Investigators

• Sponsor: Intercept Pharmaceuticals
• Investigators: Study Director: Lynda Szczech, PhD, Intercept Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): October 21, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Ursodeoxycholic acid; Primary Biliary Cholangitis; Bezafibrate; Obeticholic Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Biliary Tract Diseases; Liver Diseases; Bile Duct Diseases; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis, Biliary
• Other Study ID Numbers: 977-311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No