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

Launched by IPSEN · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called elafibranor for people with a liver disease known as Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, which can lead to serious problems like liver scarring and possibly the need for a liver transplant. The goal of the study is to gather information on how well elafibranor works and how well it's tolerated by patients in real-life situations. Participants in the study will be monitored for a total of 24 months.

To join the study, participants must have a confirmed diagnosis of PBC and should be starting elafibranor treatment for the first time, as decided by their doctor. They need to provide written consent to participate, and if they have a caregiver, that person may also need to help with some questionnaires. It’s important to note that people who have already started elafibranor or who are involved in other drug studies may not be eligible. This study aims to provide valuable insights that could help improve treatment for individuals with PBC.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant has provided written informed consent and agrees to comply with the study protocol.
• • Participant with PBC diagnosis.
• • Participant naïve to elafibranor, for whom the treating physician has decided to start treatment with 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 who started elafibranor treatment before baseline visit.
• • Participant is currently participating in, plans to participate in or has participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives of the drug/active substance, whichever is longer, prior to baseline visit.
• • 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.