Recruiting

Elafibranor

Sponsor:

Ipsen

Code:

NCT06447168

Conditions

Primary Biliary Cholangitis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Primary Biliary Cholangitis

Study ID

NCT06447168

Start date

Oct 14, 2024

Status verified date

Aug, 2026

Completion date

Jul 15, 2032

Anticipated

Primary completion date

Jul 15, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

424 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Percentage of participants with response to treatment [ Time Frame: At month 6 ]

Central Contacts and Locations

Central contacts

Ipsen Clinical Study Enquiries

See e mailclinical.trials@ipsen.com

Locations

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

University of California Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

South Denver Gastroenterology,P.C.

Recruiting

Englewood, Colorado, United States, 80113

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Schiff Center for Liver Diseases - University of Miami

Recruiting

Miami, Florida, United States, 33136

Beth Israel Deaconess Medical Center, Liver Research Center

Recruiting

Boston, Massachusetts, United States, 02215

Virtua Center for Liver Disease - Cherry Hill

Recruiting

Cherry Hill, New Jersey, United States, 08034

Northwell Health Inc, Center for Liver Disease and Transplantation

Recruiting

Manhasset, New York, United States, 11030

UNC Hospitals, The University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Liver Center of Texas

Recruiting

Dallas, Texas, United States, 75234

Baylor College of Medicine - Advanced Liver Therapies

Recruiting

Houston, Texas, United States, 77030

Texas Digestive Specialists

Recruiting

McAllen, Texas, United States, 78504

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond

Recruiting

Richmond, Virginia, United States, 23226

Virginia Commonwealth University Medical Center - West Hospital

Recruiting

Richmond, Virginia, United States, 23298

Velocity Clinical Research

Recruiting

Seattle, Washington, United States, 98105

Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

University of Calgary

Recruiting

Calgary, Canada

London Health Sciences Centre (LHSC) - University Hospital

Recruiting

London, Canada

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Canada

(G.I.R.I) GI Research Institute Foundation

Recruiting

Vancouver, Canada

More Information

Sponsor

Ipsen

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ipsen on 2026-08-31.