This study focuses on Primary Biliary Cholangitis (PBC), a long-term liver disease that causes the bile ducts in the liver to become damaged. The research evaluates a medication called elafibranor in patients who have not responded well to or cannot tolerate standard treatment with ursodeoxycholic acid. The purpose is to determine if elafibranor can help normalize liver enzyme levels in adults with this condition.
The study will test film-coated tablets containing 80 mg of elafibranor compared to placebo in adult patients. The treatment will be given as a daily oral dose for 52 weeks. During this time, researchers will monitor changes in liver function, particularly focusing on levels of alkaline phosphatase, an enzyme that indicates liver health.
Throughout the study, participants will have their symptoms assessed, including itching severity and quality of life. The research will also track any changes in liver function tests and monitor the overall safety of the treatment. The study uses various questionnaires to measure how participants feel and function during their daily activities while receiving the treatment.



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