Elafibranor in Primary Biliary Cholangitis
Condition: Primary biliary cholangitis
Key Inclusion Criteria
- 18-75 years old
- Definite or probable diagnosis of primary biliary cholangitis
- Individuals in whom it is safe and practical to proceed with a liver biopsy
Key Exclusion Criteria
- History or presence of other concomitant liver disease
- Clinically significant hepatic decompensation
- Medical conditions that may cause non-hepatic increases in alkaline phosphatase (ALP) which may diminish life expectancy to less than 2 years
Full Study Name
A Double-Blind, Randomized, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid (GFT505B-319-1) (IRB no. 00000987)
This study focuses on individuals who have been diagnosed with primary biliary cholangitis (PBC), a chronic liver disease resulting from progressive destruction of the liver bile ducts (intrahepatic bile ducts) and buildup of bile acids leading to inflammation and scarring of the liver (fibrosis). The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called elafibranor in patients with PBC who have inadequate response to or cannot tolerate standard therapy for PBC.
Researchers will compare the effects of elafibranor against the effects of placebo (inactive substance). Participants will be randomly assigned to one of two treatment groups. One group will receive 80 mg of elafibranor, and the other will receive placebo.