Actively Recruiting
Prospective Non-interventional Multicentre Study to Assess Effectiveness, Safety, and Tolerability of Elafibranor 80 mg/Day in Primary Biliary Cholangitis Patients in Real-World Treatment
Led by Ipsen · Updated on 2026-05-28
424
Participants Needed
68
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing the real-world use of the drug elafibranor in people with Primary Biliary Cholangitis (PBC), a rare progressive liver disease where bile ducts are damaged. This damage can cause liver scarring and symptoms like itching and fatigue. The study aims to collect information on how effective, safe, and tolerable elafibranor is for PBC patients receiving ongoing treatment. Each participant will be part of the study for about 5 years. Participants will continue their treatment with elafibranor as prescribed by their doctors while researchers gather data without altering care. The study monitors participants over a 60-month period, collecting information during routine physician follow-up visits. There is no placebo or comparison group since this is an observational study focusing on real-world use of elafibranor. During the study, researchers will track treatment response at 6 months and follow liver function tests, symptom changes like itching and fatigue, quality of life, liver stiffness, and safety measures up to 5 years. They will also assess participant satisfaction and adherence to treatment. Data is collected during regular medical visits, making participation flexible and integrated with usual care.
CONDITIONS
Brief Title
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided written informed consent and agrees to comply with the study protocol.
- Participant has a diagnosis of Primary Biliary Cholangitis (PBC).
- Participant is starting or currently receiving treatment with commercially available elafibranor.
- If applicable, caregiver consents to complete caregiver questionnaires before data collection.
You will not qualify if you...
- Participant is currently enrolled or plans to enroll in another investigational drug or medical device study.
- Participant has known hypersensitivity to elafibranor or any of its ingredients.
- Participant has mental instability or incompetence that may affect informed consent validity or study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months
Participants who are receiving ongoing treatment with elafibranor are observed during routine physician follow-up visits to assess effectiveness, safety, and tolerability.
Routine physician follow-up visits up to 60 months
Trial Site Locations
Total: 68 locations
1
Southern California Research Center
Coronado, California, United States, 92118
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
3
University of California Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
4
South Denver Gastroenterology,P.C.
Englewood, Colorado, United States, 80113
Actively Recruiting
5
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
Schiff Center for Liver Diseases - University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
7
Beth Israel Deaconess Medical Center, Liver Research Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Virtua Center for Liver Disease - Cherry Hill
Cherry Hill, New Jersey, United States, 08034
Actively Recruiting
9
Northwell Health Inc, Center for Liver Disease and Transplantation
Manhasset, New York, United States, 11030
Actively Recruiting
10
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
13
Liver Center of Texas
Dallas, Texas, United States, 75234
Actively Recruiting
14
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States, 77030
Actively Recruiting
15
Gastro health & Nutrition
Katy, Texas, United States, 77494
Withdrawn
16
Texas Digestive Specialists
McAllen, Texas, United States, 78504
Actively Recruiting
17
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
18
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States, 23226
Actively Recruiting
19
Virginia Commonwealth University Medical Center - West Hospital
Richmond, Virginia, United States, 23298
Actively Recruiting
20
Velocity Clinical Research
Seattle, Washington, United States, 98105
Actively Recruiting
21
St Vincent's Hospital
Fitzroy, Australia, 3065
Not Yet Recruiting
22
Medizinische Universitaetsklinik Graz
Graz, Austria
Actively Recruiting
23
Medical University Innsbruck
Innsbruck, Austria
Actively Recruiting
24
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria
Actively Recruiting
25
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, Quebec, Canada, H2X 0A9
Not Yet Recruiting
26
University of Calgary
Calgary, Canada
Actively Recruiting
27
London Health Sciences Centre (LHSC) - University Hospital
London, Canada
Actively Recruiting
28
The Ottawa Hospital - General Campus
Ottawa, Canada
Actively Recruiting
29
(G.I.R.I) GI Research Institute Foundation
Vancouver, Canada
Actively Recruiting
30
Charite Universitatsmedizin Berlin
Berlin, Germany
Actively Recruiting
31
DRK Kliniken Berlin Mitte
Berlin, Germany
Actively Recruiting
32
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany
Not Yet Recruiting
33
Studiengesellschaft BSF
Halle, Germany
Actively Recruiting
34
Gastroenterologsiche Studiengesellschaft Herne
Herne, Germany
Actively Recruiting
35
Universitaet des Saarlandes
Homburg, Germany
Actively Recruiting
36
Universitaetsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
37
Hospital of the Merciful Brothers Trier
Trier, Germany
Withdrawn
38
General Hospital of Athens Laiko
Athens, Greece
Actively Recruiting
39
University Hospital of Heraklion
Heraklion, Greece
Actively Recruiting
40
University General Hospital of Larissa
Larissa, Greece
Actively Recruiting
41
University General Hospital of Patras
Pátrai, Greece
Actively Recruiting
42
Ippokratio General Hospital of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
43
ASST-Ospedale Papa Giovanni XXIII
Bergamo, Italy
Not Yet Recruiting
44
Ospedale Garibaldi Nesima
Catania, Italy
Actively Recruiting
45
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, Italy
Actively Recruiting
46
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
47
Ospedale Maggiore Della Carita
Novara, Italy
Actively Recruiting
48
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, Italy
Not Yet Recruiting
49
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Actively Recruiting
50
Hospital de Torrecardenas
Almería, Spain
Actively Recruiting
51
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, Spain
Actively Recruiting
52
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
53
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain, 28007
Actively Recruiting
54
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Spain
Actively Recruiting
55
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, Spain
Actively Recruiting
56
Clemenceau Medical Center Hospital
Dubai, United Arab Emirates
Not Yet Recruiting
57
Mediclinic Airport Road Hospital
Dubai, United Arab Emirates
Actively Recruiting
58
Rashid Hospital
Dubai, United Arab Emirates
Not Yet Recruiting
59
Sheikh Shakhbout Medical City
Dubai, United Arab Emirates
Actively Recruiting
60
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen, United Kingdom
Actively Recruiting
61
Belfast Health and Social Care Trust - Royal Victoria Hospital
Belfast, United Kingdom
Actively Recruiting
62
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Actively Recruiting
63
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, United Kingdom
Actively Recruiting
64
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Actively Recruiting
65
King's College Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
66
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle, United Kingdom
Actively Recruiting
67
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Not Yet Recruiting
68
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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