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, 2026
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Liver Disorders

Primary Biliary Cholangitis

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 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Participant with PBC diagnosis.

  • Participant for whom the treating physician has decided to start or participants whoare currently receiving treatment with commercialized 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 is currently participating or, plans to participate in aninvestigational 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 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

  • St Vincent's Hospital

    Fitzroy, 3065
    Australia

    Site Not Available

  • Medizinische Universitaetsklinik Graz

    Graz,
    Austria

    Active - Recruiting

  • Medical University Innsbruck

    Innsbruck,
    Austria

    Active - Recruiting

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz,
    Austria

    Active - Recruiting

  • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • University of Calgary

    Calgary,
    Canada

    Active - Recruiting

  • London Health Sciences Centre (LHSC) - University Hospital

    London,
    Canada

    Active - Recruiting

  • The Ottawa Hospital - General Campus

    Ottawa,
    Canada

    Active - Recruiting

  • (G.I.R.I) GI Research Institute Foundation

    Vancouver,
    Canada

    Active - Recruiting

  • Charite Universitatsmedizin Berlin

    Berlin,
    Germany

    Active - Recruiting

  • DRK Kliniken Berlin Mitte

    Berlin,
    Germany

    Active - Recruiting

  • DRK Kliniken Berlin Mitte

    Berlin 2950159,
    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

    Site Not Available

  • General Hospital of Athens Laiko

    Athens,
    Greece

    Active - Recruiting

  • University Hospital of Heraklion

    Heraklion,
    Greece

    Active - Recruiting

  • University General Hospital of Larissa

    Larissa,
    Greece

    Active - Recruiting

  • University General Hospital of Patras

    Pátrai,
    Greece

    Active - Recruiting

  • Ippokratio General Hospital of Thessaloniki

    Thessaloniki,
    Greece

    Active - Recruiting

  • ASST-Ospedale Papa Giovanni XXIII

    Bergamo,
    Italy

    Site Not Available

  • Ospedale Garibaldi Nesima

    Catania,
    Italy

    Active - Recruiting

  • Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)

    Florence,
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan,
    Italy

    Active - Recruiting

  • Ospedale Maggiore Della Carita

    Novara,
    Italy

    Active - Recruiting

  • A. Gemelli University Hospital, Catholic University of the Sacred Heart

    Roma,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma,
    Italy

    Active - Recruiting

  • A. Gemelli University Hospital, Catholic University of the Sacred Heart

    Roma 8957247,
    Italy

    Site Not Available

  • Hospital de Torrecardenas

    Almería,
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona 3128760,
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Pontevedra

    Pontevedra,
    Spain

    Active - Recruiting

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander,
    Spain

    Active - Recruiting

  • Clemenceau Medical Center Hospital

    Dubai,
    United Arab Emirates

    Site Not Available

  • Mediclinic Airport Road Hospital

    Dubai,
    United Arab Emirates

    Active - Recruiting

  • Rashid Hospital

    Dubai,
    United Arab Emirates

    Site Not Available

  • Sheikh Shakhbout Medical City

    Dubai,
    United Arab Emirates

    Active - Recruiting

  • Clemenceau Medical Center Hospital

    Dubai 292223,
    United Arab Emirates

    Site Not Available

  • Mediclinic Airport Road Hospital

    Dubai 292223,
    United Arab Emirates

    Site Not Available

  • Sheikh Shakhbout Medical City

    Dubai 292223,
    United Arab Emirates

    Active - Recruiting

  • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board

    Aberdeen,
    United Kingdom

    Active - Recruiting

  • Belfast Health and Social Care Trust - Royal Victoria Hospital

    Belfast,
    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

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • South Denver Gastroenterology,P.C.

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    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

    Active - Recruiting

  • Virtua Center for Liver Disease - Cherry Hill

    Cherry Hill, New Jersey 08034
    United States

    Active - Recruiting

  • 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

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • 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

  • Gastro health & Nutrition

    Katy, Texas 77494
    United States

    Site Not Available

  • Texas Digestive Specialists

    McAllen, Texas 78504
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Katy 4702732, Texas 4736286 77494
    United States

    Active - Recruiting

  • Intermountain Medical Center

    Murray, Utah 84107
    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

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

    Richmond 4781708, Virginia 6254928 23226
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Gastro health & Nutrition

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

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