A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

NCT06447168 · tracked via the Priya Life Science UK tracker

Sponsor

Ipsen

Phase

Observational

Started

2024-10-14

Last updated

2026-08-31

Condition(s) studied

Primary Biliary Cholangitis

Study 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).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Percentage of participants with response to treatment — At month 6
Defined as alkaline phosphatase (ALP) \<1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.

Trial sites (74)

Facility	City	Region	Status
Southern California Research Center	Coronado	California	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Not Yet Recruiting
University of California Davis Medical Center	Sacramento	California	Recruiting
South Denver Gastroenterology,P.C.	Englewood	Colorado	Recruiting
Yale University School of Medicine	New Haven	Connecticut	Recruiting
Schiff Center for Liver Diseases - University of Miami	Miami	Florida	Recruiting
Beth Israel Deaconess Medical Center, Liver Research Center	Boston	Massachusetts	Recruiting
Virtua Center for Liver Disease - Cherry Hill	Cherry Hill	New Jersey	Recruiting
Northwell Health Inc, Center for Liver Disease and Transplantation	Manhasset	New York	Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Medical University of South Carolina (MUSC)	Charleston	South Carolina	Recruiting
Liver Center of Texas	Dallas	Texas	Recruiting
Baylor College of Medicine - Advanced Liver Therapies	Houston	Texas	Recruiting
Gastro health & Nutrition	Katy	Texas	Withdrawn
Texas Digestive Specialists	McAllen	Texas	Recruiting
Intermountain Medical Center	Murray	Utah	Recruiting
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond	Richmond	Virginia	Recruiting
Virginia Commonwealth University Medical Center - West Hospital	Richmond	Virginia	Recruiting
Velocity Clinical Research	Seattle	Washington	Recruiting
Royal Prince Alfred Hospital	Camperdown	Australia	Recruiting
St Vincent's Hospital	Fitzroy	Australia	Recruiting
Medizinische Universitaetsklinik Graz	Graz	Austria	Recruiting
Medical University Innsbruck	Innsbruck	Austria	Recruiting
Ordensklinikum Linz GmbH Barmherzige Schwestern	Linz	Austria	Recruiting
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)	Montreal	Quebec	Recruiting
University of Calgary	Calgary	Canada	Recruiting
London Health Sciences Centre (LHSC) - University Hospital	London	Canada	Recruiting
The Ottawa Hospital - General Campus	Ottawa	Canada	Recruiting
(G.I.R.I) GI Research Institute Foundation	Vancouver	Canada	Recruiting
Charite Universitatsmedizin Berlin	Berlin	Germany	Recruiting
DRK Kliniken Berlin Mitte	Berlin	Germany	Recruiting
Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt	Germany	Not Yet Recruiting
Studiengesellschaft BSF	Halle	Germany	Recruiting
Gastroenterologsiche Studiengesellschaft Herne	Herne	Germany	Recruiting
Universitaet des Saarlandes	Homburg	Germany	Recruiting
Universitaetsklinikum Leipzig	Leipzig	Germany	Recruiting
Hospital of the Merciful Brothers Trier	Trier	Germany	Withdrawn
General Hospital of Athens Laiko	Athens	Greece	Recruiting
University Hospital of Heraklion	Heraklion	Greece	Recruiting

+ 34 more sites — see the full list on the official registry below.

More Ipsen trials in the UK

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults Active, not recruiting

A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults Recruiting

A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development Active, not recruiting

A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults Active, not recruiting

Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) Active, not recruiting

Other trials for the same condition

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Recruiting

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06447168 on ClinicalTrials.gov ↗ ← All trials in the UK