To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Registration Number
- NCT06488911
- Lead Sponsor
- Intercept Pharmaceuticals
- 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 Cholangitis (PBC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 133
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OCA 5 mg + BZF 400 mg SR FDC tablet (OCA 5 mg + BZF 400 mg SR) Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.
- Primary Outcome Measures
Name Time Method Number of participants reporting adverse events (AE) and serious adverse event (SAE) Up to 60 months
- Secondary Outcome Measures
Name Time Method Number of participants reporting all-cause mortality Up to 60 months Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score Up to 60 months 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').
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 - Liver transplant Up to 60 months Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score ≥15 Up to 60 months 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.
Trial Locations
- Locations (53)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Southern California Research Center
🇺🇸Coronado, California, United States
University of Miami/Schiff Center for Liver Diseases
🇺🇸Miami, Florida, 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
Carolina's GI Research, LLC
🇺🇸Raleigh, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Scroll for more (43 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States