A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis (ELFIDENCE)
Research type
Research Study
Full title
A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)
IRAS ID
1009112
Contact name
David Jones
Contact email
Sponsor organisation
Ipsen Biosciences Inc.
Clinicaltrials.gov Identifier
Research summary
The people invited to take part in this study will have a confirmed diagnosis of the chronic liver disease Primary Biliary Cholangitis (PBC), and will have been found to have not responded sufficiently to the standard treatment ursodeoxycholic acid (UDCA or “urso” as it is usually called by patients. People with PBC who are not able to take UDCA because of side effects can also potentially take part in this study. PBC is a disease that slowly damages the bile ducts in the liver (the tubes that normally drain bile out of the liver), leading to a build-up of bile which causes further bile duct damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with lots of symptoms, including itch and tiredness. People with PBC who aren’t treated adequately may require liver transplant or even die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of a drug called elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). Each participant will be in the study up to about 7 years. The main aim of this study is to determine if elafibranor is better than placebo in preventing deterioration in the liver (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness. Elafibranor has already been shown to reliably improve liver blood tests in PBC. This follow on study is designed to show whether this blood test improvement is matched by a real reduction in risk to life of liver complications.
REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0027
Date of REC Opinion
31 Jan 2024
REC opinion
Further Information Unfavourable Opinion