A Double-Blind Randomized Placebo-Controlled Study and Open-Label Long Term Extension of study drug in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid

Brief description of study

The main purpose is to study the effect of daily oral administration of 80 mg elafibranor on cholestasis (impairment of bile formation and/or bile accumulation) in patients with Primary Biliary Cholangitis (PBC) and their inadequate response or intolerance to ursodeoxycholic Acid (UCDA). Primary Biliary Cholangitis (PBC) is a chronic liver disease resulting from progressive destruction of the liver bile ducts, also called the intrahepatic bile ducts. The effect and the safety and tolerability of elafibranor 80 mg will be compared with placebo over a period of 1 to 2 years. The maintenance of the effect and the safety and tolerability of elafibranor 80 mg will continue to be studied during a period of up to 5 years. There is no cure for PBC; however, there are medications that can help slow down disease progression and manage symptoms.


Clinical Study Identifier: s20-00100
ClinicalTrials.gov Identifier: NCT04526665
Principal Investigator: Carmen M. Stanca.
Other Investigator: Viviana Figueroa Diaz.


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