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

Description

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.

Conditions

Primary Biliary Cholangitis

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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.

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

Condition
Primary Biliary Cholangitis
Intervention / Treatment

-

Contacts and Locations

Katy

Velocity Clinical Research, Katy, Texas, United States, 77494

Seattle

Gastro health & Nutrition, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ipsen,

Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

2029-07-15