Not currently recruiting at University of California Health

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

a study on Primary Biliary Cholangitis Cirrhosis

Summary

Location
at UC Davis
Dates
study started
study ends around

Description

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 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).

Official Title

Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.

Keywords

Primary Biliary Cholangitis, Biliary Liver Cirrhosis

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Davis Medical Center not yet accepting patients
    Sacramento 5389489 California 5332921 95817 United States
  • Cedars-Sinai Medical Center not yet accepting patients
    Los Angeles 5368361 California 5332921 90048 United States
  • Southern California Research Center accepting new patients
    Coronado 5339663 California 5332921 92118 United States
  • South Denver Gastroenterology,P.C. accepting new patients
    Englewood 5421250 Colorado 5417618 80113 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Ipsen
ID
NCT06447168
Study Type
Observational
Participants
Expecting 424 study participants
Last Updated