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

Last updated: May 27, 2025
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Liver Disease

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT06447168
CLIN-60190-461
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has provided written informed consent and agrees to comply with thestudy protocol.

  • Participant with PBC diagnosis.

  • Participant naïve to elafibranor, for whom the treating physician has decided tostart treatment with elafibranor.

  • If a participant has a caregiver who agrees to complete the caregiverquestionnaires, an informed consent should be collected from the caregiver beforeany data is collected.

Exclusion

Exclusion Criteria:

  • Participant who started elafibranor treatment before baseline visit.

  • Participant is currently participating in, plans to participate in or hasparticipated in an investigational drug study or medical device study containingactive 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 ofinformed consent or ability to be compliant with the study is uncertain.

Study Design

Total Participants: 424
Study Start date:
October 14, 2024
Estimated Completion Date:
July 15, 2032

Connect with a study center

  • Medizinische Universitaetsklinik Graz

    Graz,
    Austria

    Active - Recruiting

  • Medical University Innsbruck

    Innsbruck,
    Austria

    Active - Recruiting

  • Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III

    Vienna,
    Austria

    Site Not Available

  • University of Calgary

    Calgary,
    Canada

    Site Not Available

  • Charite Universitatsmedizin Berlin

    Berlin,
    Germany

    Active - Recruiting

  • DRK Kliniken Berlin Mitte

    Berlin,
    Germany

    Active - Recruiting

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt,
    Germany

    Site Not Available

  • Studiengesellschaft BSF

    Halle,
    Germany

    Active - Recruiting

  • Gastroenterologsiche Studiengesellschaft Herne

    Herne,
    Germany

    Active - Recruiting

  • Universitaet des Saarlandes

    Homburg,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig,
    Germany

    Active - Recruiting

  • Hospital of the Merciful Brothers Trier

    Trier,
    Germany

    Active - Recruiting

  • General Hospital of Athens Laiko

    Athens,
    Greece

    Site Not Available

  • University Hospital of Heraklion

    Heraklion,
    Greece

    Site Not Available

  • University General Hospital of Patras

    Patras,
    Greece

    Site Not Available

  • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board

    Aberdeen,
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation

    Bradford,
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust

    Hull,
    United Kingdom

    Active - Recruiting

  • King's College Hospital NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

    Newcastle,
    United Kingdom

    Active - Recruiting

  • Queen's Medical Centre - Nottingham University Hospitals NHS Trust

    Nottingham,
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust

    Oxford,
    United Kingdom

    Active - Recruiting

  • Southern California Research Center

    Coronado, California 92118
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • South Denver Gastroenterology,P.C.

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • Schiff Center for Liver Diseases - University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center, Liver Research Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Virtua Center for Liver Disease - Cherry Hill

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Baylor College of Medicine - Advanced Liver Therapies

    Manhasset, New York 11030
    United States

    Site Not Available

  • Northwell Health Inc, Center for Liver Disease and Transplantation

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Liver Center of Texas

    Dallas, Texas 75234
    United States

    Active - Recruiting

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond

    Richmond, Virginia 23226
    United States

    Active - Recruiting

  • Virginia Commonwealth University Medical Center - West Hospital

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Gastro health & Nutrition

    Seattle, Washington 98105
    United States

    Site Not Available

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