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New drug elafibranor tested in everyday use for rare liver disease

NCT ID NCT06447168

Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 6 times

Summary

This study follows about 424 people with primary biliary cholangitis (PBC) who are taking elafibranor as part of their normal care. Researchers will track how well the drug controls liver damage and symptoms like itching over 5 years. The goal is to see if elafibranor works safely in real-world conditions, not just in strict clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elafibranor
What this could lead to
If successful, this could confirm that elafibranor helps control PBC in real-world patients, potentially slowing liver damage and reducing symptoms like itching.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. Elafibranor may not work for everyone and could have side effects not yet fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 424 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with PBC for whom the treating physician has decided to start treatment with elafibranor 80 mg/day, as recommended in the approved indication.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    72 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Vancouver, Canada

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

    RECRUITING

    Roma, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Italy

  • ASST-Ospedale Papa Giovanni XXIII

    RECRUITING

    Bergamo, Italy

  • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board

    RECRUITING

    Aberdeen, United Kingdom

  • Baylor College of Medicine - Advanced Liver Therapies

    RECRUITING

    Houston, Texas, 77030, United States

  • Belfast Health and Social Care Trust - Royal Victoria Hospital

    RECRUITING

    Belfast, United Kingdom

  • Beth Israel Deaconess Medical Center, Liver Research Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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

    RECRUITING

    Richmond, Virginia, 23226, United States

  • Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation

    RECRUITING

    Bradford, United Kingdom

  • Cedars-Sinai Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

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

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Charite Universitatsmedizin Berlin

    RECRUITING

    Berlin, Germany

  • Clemenceau Medical Center Hospital

    NOT_YET_RECRUITING

    Dubai, United Arab Emirates

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Complexo Hospitalario Universitario de Pontevedra

    RECRUITING

    Pontevedra, Spain

  • DRK Kliniken Berlin Mitte

    RECRUITING

    Berlin, Germany

  • Fondazione Policlinico Universitario Campus Bio-Medico

    RECRUITING

    Roma, Italy

  • Gastro health & Nutrition

    WITHDRAWN

    Katy, Texas, 77494, United States

  • Gastroenterologsiche Studiengesellschaft Herne

    RECRUITING

    Herne, Germany

  • General Hospital of Athens Laiko

    RECRUITING

    Athens, Greece

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    RECRUITING

    Barcelona, Spain

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital de Torrecardenas

    RECRUITING

    Almería, Spain

  • Hospital of the Merciful Brothers Trier

    WITHDRAWN

    Trier, Germany

  • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, United Kingdom

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    RECRUITING

    Santander, Spain

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Ippokratio General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, Greece

  • John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, United Kingdom

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    NOT_YET_RECRUITING

    Frankfurt, Germany

  • Liver Center of Texas

    RECRUITING

    Dallas, Texas, 75234, United States

  • London Health Sciences Centre (LHSC) - University Hospital

    RECRUITING

    London, Canada

  • Medical University Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mediclinic Airport Road Hospital

    RECRUITING

    Dubai, United Arab Emirates

  • Medizinische Universitaetsklinik Graz

    RECRUITING

    Graz, Austria

  • Northwell Health Inc, Center for Liver Disease and Transplantation

    RECRUITING

    Manhasset, New York, 11030, United States

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    RECRUITING

    Linz, Austria

  • Ospedale Garibaldi Nesima

    RECRUITING

    Catania, Italy

  • Ospedale Maggiore Della Carita

    RECRUITING

    Novara, Italy

  • Pusan National University Hospital (PNUH)

    NOT_YET_RECRUITING

    Busan, South Korea

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

    RECRUITING

    Birmingham, United Kingdom

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

    NOT_YET_RECRUITING

    Nottingham, United Kingdom

  • Rashid Hospital

    RECRUITING

    Dubai, United Arab Emirates

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, Australia

  • Samsung Medical Center

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Schiff Center for Liver Diseases - University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • Seoul National University Bundang Hospital (SNUBH)

    NOT_YET_RECRUITING

    Seongnam-si, South Korea

  • Seoul National University Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Sheikh Shakhbout Medical City

    RECRUITING

    Dubai, United Arab Emirates

  • South Denver Gastroenterology,P.C.

    RECRUITING

    Englewood, Colorado, 80113, United States

  • Southern California Research Center

    RECRUITING

    Coronado, California, 92118, United States

  • St Vincent's Hospital

    RECRUITING

    Fitzroy, 3065, Australia

  • Studiengesellschaft BSF

    RECRUITING

    Halle, Germany

  • Texas Digestive Specialists

    RECRUITING

    McAllen, Texas, 78504, United States

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

    RECRUITING

    Newcastle, United Kingdom

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ottawa, Canada

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

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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

    RECRUITING

    Florence, Italy

  • Universitaet des Saarlandes

    RECRUITING

    Homburg, Germany

  • Universitaetsklinikum Leipzig

    RECRUITING

    Leipzig, Germany

  • University General Hospital of Larissa

    RECRUITING

    Larissa, Greece

  • University General Hospital of Patras

    RECRUITING

    Pátrai, Greece

  • University Hospital of Heraklion

    RECRUITING

    Heraklion, Greece

  • University of Calgary

    RECRUITING

    Calgary, Canada

  • University of California Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • Velocity Clinical Research

    RECRUITING

    Seattle, Washington, 98105, United States

  • Virginia Commonwealth University Medical Center - West Hospital

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Virtua Center for Liver Disease - Cherry Hill

    RECRUITING

    Cherry Hill, New Jersey, 08034, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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Other studies related to the condition(s) this trial covers.