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To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT06488911•Intercept Pharmaceuticals

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Key Dates

Start Date

July 1, 2024

Primary Completion Date

October 21, 2025

Completion Date

October 21, 2025

Last Updated

October 31, 2025

Enrollment

ACTUAL participants

Conditions

Primary Biliary Cholangitis

Interventions

FDC tablet (OCA 5 mg + BZF 400 mg SR)

DRUG

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

NCT07304843

Primary Biliary Cholangitis (PBC)

View study

RECRUITING

Biochemical Response and Clinical Outcomes in Patients With PBC

NCT07449793

Primary Biliary Cholangitis (PBC)Primary Biliary Cholangitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

Biochemical Response and Clinical Outcomes in Patients With PBC

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study

FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy