- A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. — Active Not Recruiting • Phase III • Gastroenterology • NCT06383403.
- Trial testing elafibranor versus placebo in primary biliary cholangitis patients who cannot tolerate or inadequately respond to ursodeoxycholic acid, measuring effects on alkaline phosphatase levels.
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The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 patients with PBC may require a liver transplant or may…