A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
NCT ID: NCT06447168
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
424 participants
OBSERVATIONAL
2024-10-14
2032-07-15
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Southern California Research Center
Coronado, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
South Denver Gastroenterology,P.C.
Englewood, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Schiff Center for Liver Diseases - University of Miami
Miami, Florida, United States
Beth Israel Deaconess Medical Center, Liver Research Center
Boston, Massachusetts, United States
Virtua Center for Liver Disease - Cherry Hill
Cherry Hill, New Jersey, United States
Northwell Health Inc, Center for Liver Disease and Transplantation
Manhasset, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Liver Center of Texas
Dallas, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
Velocity Clinical Research
Katy, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
Virginia Commonwealth University Medical Center - West Hospital
Richmond, Virginia, United States
Gastro health & Nutrition
Seattle, Washington, United States
Medizinische Universitaetsklinik Graz
Graz, , Austria
Medical University Innsbruck
Innsbruck, , Austria
University of Calgary
Calgary, , Canada
London Health Sciences Centre (LHSC) - University Hospital
London, , Canada
The Ottawa Hospital - General Campus
Ottawa, , Canada
(G.I.R.I) GI Research Institute Foundation
Vancouver, , Canada
Charite Universitatsmedizin Berlin
Berlin, , Germany
DRK Kliniken Berlin Mitte
Berlin, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Studiengesellschaft BSF
Halle, , Germany
Gastroenterologsiche Studiengesellschaft Herne
Herne, , Germany
Universitaet des Saarlandes
Homburg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Hospital of the Merciful Brothers Trier
Trier, , Germany
General Hospital of Athens Laiko
Athens, , Greece
University Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Larissa
Larissa, , Greece
University General Hospital of Patras
Pátrai, , Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
ASST-Ospedale Papa Giovanni XXIII
Bergamo, , Italy
Ospedale Garibaldi Nesima
Catania, , Italy
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Ospedale Maggiore Della Carita
Novara, , Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Clemenceau Medical Center Hospital
Dubai, , United Arab Emirates
Mediclinic Airport Road Hospital
Dubai, , United Arab Emirates
Rashid Hospital
Dubai, , United Arab Emirates
Sheikh Shakhbout Medical City
Dubai, , United Arab Emirates
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen, , United Kingdom
Belfast Health and Social Care Trust - Royal Victoria Hospital
Belfast, , United Kingdom
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, , United Kingdom
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle, , United Kingdom
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CLIN-60190-461
Identifier Type: -
Identifier Source: org_study_id