A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
ELFINITY
Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
1 other identifier
observational
424
9 countries
65
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Longer than P75 for all trials
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2024
CompletedFirst Posted
Study publicly available on registry
June 6, 2024
CompletedStudy Start
First participant enrolled
October 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2032
April 30, 2026
April 1, 2026
7.8 years
June 3, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants with response to treatment
Defined as alkaline phosphatase (ALP) \<1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.
At month 6
Secondary Outcomes (22)
Percentage of participants with normalization of ALP levels
Up to 60 months following enrollment, based on routine physician follow-up visit
Percentage of participants with response to treatment
Up to 60 months following enrollment, based on routine physician follow-up visits
Change from baseline in liver function parameters: Serum levels of alanine aminotransferase (ALT)
Up to 60 months following enrollment, based on routine physician follow-up visit
Change from baseline in liver function parameters: Serum levels of Aspartate aminotransferase (AST)
Up to 60 months following enrollment, based on routine physician follow-up visit
Change from baseline in liver function parameters: Serum levels of Gamma-glutamyl transferase (GGT)
Up to 60 months following enrollment, based on routine physician follow-up visit
- +17 more secondary outcomes
Eligibility Criteria
Participants with PBC for whom the treating physician has decided to start treatment with elafibranor 80 mg/day, as recommended in the approved indication.
You may qualify if:
- 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 may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (65)
Southern California Research Center
Coronado, California, 92118, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
South Denver Gastroenterology,P.C.
Englewood, Colorado, 80113, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Schiff Center for Liver Diseases - University of Miami
Miami, Florida, 33136, United States
Beth Israel Deaconess Medical Center, Liver Research Center
Boston, Massachusetts, 02215, United States
Virtua Center for Liver Disease - Cherry Hill
Cherry Hill, New Jersey, 08034, United States
Northwell Health Inc, Center for Liver Disease and Transplantation
Manhasset, New York, 11030, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Liver Center of Texas
Dallas, Texas, 75234, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030, United States
Gastro health & Nutrition
Katy, Texas, 77494, United States
Texas Digestive Specialists
McAllen, Texas, 78504, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226, United States
Virginia Commonwealth University Medical Center - West Hospital
Richmond, Virginia, 23298, United States
Velocity Clinical Research
Seattle, Washington, 98105, 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
Hospital de Torrecardenas
Almería, Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007, Spain
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Spain
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, Spain
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2024
First Posted
June 6, 2024
Study Start
October 14, 2024
Primary Completion (Estimated)
July 15, 2032
Study Completion (Estimated)
July 15, 2032
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.