Actively Recruiting
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Led by Ipsen · Updated on 2026-04-30
424
Participants Needed
65
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 65 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
Not Yet 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
Medizinische Universitaetsklinik Graz
Graz, Austria
Actively Recruiting
22
Medical University Innsbruck
Innsbruck, Austria
Actively Recruiting
23
University of Calgary
Calgary, Canada
Actively Recruiting
24
London Health Sciences Centre (LHSC) - University Hospital
London, Canada
Actively Recruiting
25
The Ottawa Hospital - General Campus
Ottawa, Canada
Actively Recruiting
26
(G.I.R.I) GI Research Institute Foundation
Vancouver, Canada
Actively Recruiting
27
Charite Universitatsmedizin Berlin
Berlin, Germany
Actively Recruiting
28
DRK Kliniken Berlin Mitte
Berlin, Germany
Actively Recruiting
29
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany
Not Yet Recruiting
30
Studiengesellschaft BSF
Halle, Germany
Actively Recruiting
31
Gastroenterologsiche Studiengesellschaft Herne
Herne, Germany
Actively Recruiting
32
Universitaet des Saarlandes
Homburg, Germany
Actively Recruiting
33
Universitaetsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
34
Hospital of the Merciful Brothers Trier
Trier, Germany
Actively Recruiting
35
General Hospital of Athens Laiko
Athens, Greece
Actively Recruiting
36
University Hospital of Heraklion
Heraklion, Greece
Actively Recruiting
37
University General Hospital of Larissa
Larissa, Greece
Actively Recruiting
38
University General Hospital of Patras
Pátrai, Greece
Actively Recruiting
39
Ippokratio General Hospital of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
40
ASST-Ospedale Papa Giovanni XXIII
Bergamo, Italy
Not Yet Recruiting
41
Ospedale Garibaldi Nesima
Catania, Italy
Actively Recruiting
42
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, Italy
Actively Recruiting
43
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Not Yet Recruiting
44
Ospedale Maggiore Della Carita
Novara, Italy
Actively Recruiting
45
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, Italy
Not Yet Recruiting
46
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Actively Recruiting
47
Hospital de Torrecardenas
Almería, Spain
Not Yet Recruiting
48
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, Spain
Actively Recruiting
49
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
50
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain, 28007
Not Yet Recruiting
51
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Spain
Actively Recruiting
52
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, Spain
Actively Recruiting
53
Clemenceau Medical Center Hospital
Dubai, United Arab Emirates
Not Yet Recruiting
54
Mediclinic Airport Road Hospital
Dubai, United Arab Emirates
Actively Recruiting
55
Rashid Hospital
Dubai, United Arab Emirates
Not Yet Recruiting
56
Sheikh Shakhbout Medical City
Dubai, United Arab Emirates
Actively Recruiting
57
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen, United Kingdom
Actively Recruiting
58
Belfast Health and Social Care Trust - Royal Victoria Hospital
Belfast, United Kingdom
Actively Recruiting
59
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Actively Recruiting
60
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, United Kingdom
Actively Recruiting
61
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Actively Recruiting
62
King's College Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
63
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle, United Kingdom
Actively Recruiting
64
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Not Yet Recruiting
65
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
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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