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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Page 1 of 17 (65 locations)

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

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