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

Ipsen

Status: Enrolling

Conditions: Primary Biliary Cholangitis

Study type: Observational

Funder types: Industry

Identifiers

NCT06447168

CLIN-60190-461

Details and patient eligibility

About

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. Many participants 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 24 months.

Enrollment: 424 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.