A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Active, not recruiting · NCT06447168
Conditions: Primary Biliary Cholangitis
At a glance
- Research payments reported, 2025
- $235,544
- U.S. investigators named
- 13
- Sites paid
- 14
- Planned or actual enrollment
- 424
About the trial
- Sponsor
- Ipsen
- Dates
- Started 2024-10-14; completion 2032-07-15
- Results posted
- Not yet
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.…
From ClinicalTrials.gov, last updated 2026-10-23. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ipsen Pharma Sas reported $235,544 in research payments for this study in 2025 (52 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Walid S. Ayoub, M.D. Hepatology · West Hollywood, CA
- Marcelo Kugelmas, M.D Gastroenterology · Englewood, CO
- Marina G. Silveira, M.D. Internal Medicine · New Haven, CT
- Cynthia Levy, MD Hepatology · Miami, FL
- Alan Bonder, M.D. Internal Medicine · Boston, MA
- Sayed Obaidullah Aseem, M.D., PH.D. Gastroenterology · Rochester, MN
- Hisham Elgenaidi, MD Hepatology · Cherry Hill, NJ
- Don C. Rockey, MD Hepatology · Charleston, SC
- Sanjaya K. Satapathy, MD Gastroenterology · Memphis, TN
- Abdullah Mubarak, MD Hepatology · Tyler, TX
- Mitchell L. Shiffman, MD Gastroenterology · Newport News, VA
- Dian J. Chiang, MD Gastroenterology · Seattle, WA
- Kris V. Kowdley, MD Gastroenterology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Yale University School of Medicine $47,244
- Cleveland Clinic, OH $29,559
- University of Miami $22,593
- Feinstein Institutes for Medical Research $18,260
- Bon Secours Mercy Health, Inc $17,800
- Medical University of South Carolina $17,723
- Cedars-Sinai Medical Center, CA $17,675
- Virginia Commonwealth University $16,296
- Beth Israel Deaconess Medical Center, MA $13,309
- Velocity Clinical Research $12,230
- Summit Health Virtua, Inc $10,745
- South Denver Gastroenterology, PC $7,622
- Liver Center of Texas, PLLC $3,497
- Virtua Marlton Hospital $990
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.