Efficacy and Safety of Elafibranor in Patients with PBC
Research type
Research Study
Full title
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
IRAS ID
282292
Contact name
Michael Heneghan
Contact email
Sponsor organisation
GENFIT
Eudract number
2019-004941-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND number, 132202
Duration of Study in the UK
7 years, 9 months, 1 days
Research summary
This is 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.
PBC is a rare, chronic, progressive liver disease characterized by injury of the intrahepatic bile ducts that, in untreated patients or non-responders to existing therapies, may progress to hepatic fibrosis, cirrhosis, hepatic decompensation, and death unless they receive a liver transplant. Elafibranor is being developed by Genfit for the treatment of PBC, based on its pharmacological properties.
This Phase 3 study is being conducted to evaluate the effect of Elafibranor on cholestasis (reduction or stoppage of bile flow) over 52 weeks of the treatment compared to placebo.
The total duration of a patients participation is up to approximately 6 years, or 328 weeks (2 to 12 weeks for the screening period, 52 to 104 weeks for the DB period, 208 to 260 weeks for the LTE period, and 4 weeks for safety follow-up).
The study will take place at NHS sites in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/1207
Date of REC Opinion
11 Feb 2021
REC opinion
Further Information Favourable Opinion