Status:
TERMINATED
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Lead Sponsor:
Intercept Pharmaceuticals
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Cholan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06488911
Start Date
July 1 2024
End Date
October 21 2025
Last Update
October 31 2025
Active Locations (51)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Southern California Research Center
Coronado, California, United States, 92118
3
Tampa General Medical Group
Tampa, Florida, United States, 33606
4
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309