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First received: August 22, 2023

Clinical Trial: A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

Study Status: Completed

Recruit Status: RECRUITING

Condition: Primary Biliary Cholangitis (PBC)

Study Type: INTERVENTIONAL


Official 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 Wi

Brief Summary: The participants of this study will have confirmed Primary Biliary Cholangitis (PBC).Participants will also have inadequate response or intolerance to ursodeoxycholic acid (UDCA) a drug used to treat PBC.PBC is a disease that progresses slowly.It causes damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.The liver damage in PBC may lead to scarring (cirrhosis).PBC may also be associated with multiple symptoms.Many people with PBC may require liver transplant or…

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