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

Recruiting now

Conditions studied: Primary Biliary Cholangitis

In brief

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).

Key facts

Study ID

NCT06447168

Run by

Ipsen

People needed

424

Starts

2024-10-14

Expected to finish

2032-07-15

Last updated by the study team

2026-08-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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.

Where it is running

• Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) — Montreal, Quebec, Canada (enrolling)
• University of Calgary — Calgary, Canada (enrolling)
• South Denver Gastroenterology,P.C. — Englewood, Colorado, United States (enrolling)
• Southern California Research Center — Coronado, California, United States (enrolling)
• Schiff Center for Liver Diseases - University of Miami — Miami, Florida, United States (enrolling)
• University of California Davis Medical Center — Sacramento, California, United States (enrolling)
• Virtua Center for Liver Disease - Cherry Hill — Cherry Hill, New Jersey, United States (enrolling)
• Northwell Health Inc, Center for Liver Disease and Transplantation — Manhasset, New York, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (enrolling)
• Liver Center of Texas — Dallas, Texas, United States (enrolling)
• Baylor College of Medicine - Advanced Liver Therapies — Houston, Texas, United States (enrolling)
• Beth Israel Deaconess Medical Center, Liver Research Center — Boston, Massachusetts, United States (enrolling)
• Texas Digestive Specialists — McAllen, Texas, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond — Richmond, Virginia, United States (enrolling)
• Virginia Commonwealth University Medical Center - West Hospital — Richmond, Virginia, United States (enrolling)
• Velocity Clinical Research — Seattle, Washington, United States (enrolling)
• UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• St Vincent's Hospital — Fitzroy, Australia (enrolling)
• Medizinische Universitaetsklinik Graz — Graz, Austria (enrolling)
• Medical University Innsbruck — Innsbruck, Austria (enrolling)
• Ordensklinikum Linz GmbH Barmherzige Schwestern — Linz, Austria (enrolling)
• London Health Sciences Centre (LHSC) - University Hospital — London, Canada (enrolling)

Full record on ClinicalTrials.gov

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