NCT06447168

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 424 (estimated)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).

Conditions

• Primary Biliary Cholangitis

Timeline

• Start date: 2024-10-14
• Primary completion: 2032-07-15
• Completion: 2032-07-15
• First posted: 2024-06-06
• Last updated: 2026-04-01

Locations

65 sites across 9 countries: United States, Austria, Canada, Germany, Greece, Italy, Spain, United Arab Emirates, United Kingdom