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Clinical Trial Active — Not Recruiting Phase III NCT06383403

A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. — Active Not Recruiting • Phase III • Gastroenterology •…

📅 30 Apr 2026 ⏱ 2 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT06383403
Start
2024-07-09
Completion
2026-06-26
ClinicaliQ Trial Snapshot
  • 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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What This Trial Is Studying

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…

Full Trial Details
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Eligibility criteria, protocol, and results when available
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