Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).
- Conditions
- Primary biliary cholangitisMedDRA version: 27.0Level: PTClassification code: 10080429Term: Primary biliary cholangitis Class: 100000004871Therapeutic area: Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- CTIS2024-513584-77-00
- Lead Sponsor
- Intercept Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
A define or probable diagnosis of PBC, Qualifying ALP and/or bilirubin liver biochemistry values, Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
History or presence of other concomitant liver diseases, Presence of clinical complications of PBC, History or presence of 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., Treatment with commercially available OCA or participation in aprevious study involving OCA within 3 months before Screening, Treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method