A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Part of paid clinical trials in Coronado, California.
- Sponsor
- Ipsen
- Study ID
- NCT06447168
- Status
- Recruiting
Conditions
- Primary Biliary Cholangitis
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Study Details
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).
Key Dates
- Start date
- Oct 14, 2024
- Status verified
- May 2026
- Primary completion
- Jul 15, 2032
- Completion
- Jul 15, 2032
Study Design
- Enrollment
- 424 participants (estimated)
Primary Outcome Measure
Percentage of participants with response to treatment [ Time Frame: At month 6 ]
Central Contacts
- Ipsen Clinical Study EnquiriesSee e mail
Locations (20)
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