Status:
RECRUITING
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Lead Sponsor:
Ipsen
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
Brief 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 t...
Eligibility Criteria
Inclusion Criteria:
- Participant has provided written informed consent and agrees to comply with the study protocol.
- Participant with PBC diagnosis.
- Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.
- If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Exclusion Criteria:
- Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.
- Participant with known hypersensitivity to the product or to any of its excipients.
- Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Key Trial Info
Start Date :
October 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 15 2032
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT06447168
Start Date
October 14 2024
End Date
July 15 2032
Last Update
April 1 2026
Active Locations (65)
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1
Southern California Research Center
Coronado, California, United States, 92118
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of California Davis Medical Center
Sacramento, California, United States, 95817
4
South Denver Gastroenterology,P.C.
Englewood, Colorado, United States, 80113