Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Active, not recruiting · Phase 3 · NCT04526665
Conditions: Primary Biliary Cirrhosis
At a glance
- Research payments reported, 2025
- $1.6M
- U.S. investigators named
- 51
- Sites paid
- 62
- Planned or actual enrollment
- 161
About the trial
- Sponsor
- Ipsen
- Tested
- Elafibranor 80mg (drug), Placebo (drug)
- Dates
- Started 2020-09-24; completion 2028-12-01
- Results posted
- Yes
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. The main aim of this study is to determine if elafibranor (the stud…
From ClinicalTrials.gov, last updated 2026-11-05. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ipsen Bioscience Inc. reported $1.6M in research payments for this study in 2025 (693 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
- Anita Kohli, MD Infectious Disease · Chandler, AZ
- Walid S. Ayoub, M.D. Hepatology · West Hollywood, CA
- Christopher L. Bowlus, M.D. Gastroenterology · Sacramento, CA
- Tarek I. Hassanein, M.D. Hepatology · Coronado, CA
- Nicholas Karyotakis, MD Gastroenterology · Los Angeles, CA
- Saro Khemichian, M.D. Hepatology · Los Angeles, CA
- Peter Ruane, MD Infectious Disease · Los Angeles, CA
- Kidist K. Yimam, M.D. Hepatology · San Francisco, CA
- Bahri M. Bilir, MD Gastroenterology · Littleton, CO
- Lisa Forman, MD Hepatology · Aurora, CO
- Marcelo Kugelmas, M.D Gastroenterology · Englewood, CO
- Bhaktasharan C. Patel, MD Gastroenterology · Colorado Springs, CO
- Marina G. Silveira, M.D. Internal Medicine · New Haven, CT
- Ana M. Corregidor, MD Gastroenterology · Jacksonville, FL
- Cynthia Levy, MD Hepatology · Miami, FL
- Angel M. Rosario, MD Gastroenterology · Tampa, FL
- Humberto I. Aguilar, M.D. Gastroenterology · Shreveport, LA
- Daniel S. Pratt, MD Gastroenterology · Boston, MA
- Michael R. Fine, MD Gastroenterology · Ypsilanti, MI
- Anna S. Lok, MD Gastroenterology · Ann Arbor, MI
- Hany A. Elbeshbeshy, MD Hepatology · Saint Louis, MO
- Matthew R. Kappus, MD Gastroenterology · Durham, NC
- Antoine Jakiche, M.D. Gastroenterology · Albuquerque, NM
- Ira M. Jacobson, MD Gastroenterology · New York, NY
- Sonal Kumar, MD Gastroenterology · New York, NY
- Naim Alkhouri, MD Gastroenterology · Westlake, OH
- Anthony B. Post, MD Gastroenterology · Cleveland, OH
- Ravi V. Ravinuthala, M.D. Gastroenterology · Cincinnati, OH
- Tien S. Dong, M.D., PH.D. Gastroenterology · Portland, OR
- Karen L. Krok, MD Gastroenterology · Hershey, PA
- Mordechai Rabinovitz Specialist · Pittsburgh, PA
- David A. Sass, MD Gastroenterology · Philadelphia, PA
- Don C. Rockey, MD Hepatology · Charleston, SC
- Andrew E. Scanga, MD Hepatology · Nashville, TN
- Ziad H. Younes, M.D. Gastroenterology · Germantown, TN
- Victor Ankoma-sey, M.D. Gastroenterology · Houston, TX
- Manjushree Gautam, M.D. Gastroenterology · Fort Worth, TX
- Reem H. Ghalib, MD Gastroenterology · Arlington, TX
- Nadege T. Gunn, M.D. Gastroenterology · Waco, TX
- Carmen E. Landaverde, M.D. Hepatology · San Antonio, TX
- Eric J. Lawitz, M.D. Gastroenterology · San Antonio, TX
- Parvez Mantry, MD Gastroenterology · Dallas, TX
- Marlyn J. Mayo, MD Hepatology · Dallas, TX
- Abdullah Mubarak, MD Hepatology · Tyler, TX
- Fabian V. Rodas Ochoa, MD Internal Medicine · San Antonio, TX
- David W. Victor III, M.D. Hepatology · Houston, TX
- John M. Vierling, MD Gastroenterology · Houston, TX
- Stephen H. Caldwell Gastroenterology · Charlottesville, VA
- Velimir A. Luketic, M.D. Gastroenterology · Richmond, VA
- Mitchell L. Shiffman, MD Gastroenterology · Newport News, VA
- Kris V. Kowdley, MD Gastroenterology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- American Research Corporation $257,703
- Gastro One $141,126
- Sc Liver Research Consortium $97,566
- Duke University Medical Center $77,084
- University of Michigan Health System, MI $71,070
- Bon Secours Mercy Health, Inc $48,084
- Regents of the University of Colorado $47,293
- Texas Clinical Research Institute $41,976
- Medical University of South Carolina $39,177
- Topography Health Inc $36,211
- Velocity Clinical Research $33,958
- University Texas Southwestern Medical Center $28,746
- The University of Texas Southwestern Medical Center $28,297
- Southern California Research Center $28,009
- Virginia Commonwealth University $26,919
- Ruane Clinical Research Group, Inc $26,766
- Arizona Liver Health $26,694
- University of Miami $25,980
- Louisiana Research Center, Llc $25,027
- Cedars-Sinai Medical Center, CA $24,690
- Methodist Dallas Medical Center, TX $24,037
- University of Pittsburgh Physicians $22,000
- Yale University School of Medicine $20,758
- Cedars Sinai Medical Center $20,507
- University of Virginia Medical Center, VA $19,550
- The Rector and Visitors of the University of Virginia $18,770
- University of California Davis Medical Center $18,312
- South Denver Gastroenterology, PC $18,228
- $17,040
- Peak Gastroenterology Associates, PC $16,425
- Ronald Reagan UCLA Medical Center, CA $16,217
- California PAcific Medical Center Research Institute $15,571
- University of Southern California $15,124
- Adventhealth Medical Group Gastroenterology at Carrollwood $15,116
- Liver Center of Texas, PLLC $13,927
- Liver Associates of Texas, PA $13,542
- Gastro Health $13,191
- Duke Cancer Center $12,074
- University of Miami Miller School of Medicine $11,025
- Pennsylvania State University College of Medicine $10,090
- Thomas Jefferson University Research and Development $9,537
- Vanderbilt University Medical Center $9,055
- Ut Southwestern Medical Center $8,395
- Uh Cleveland Medical Center, OH $7,795
- Massachusetts General Hospital $7,579
- NYU Grossman School of Medicine $6,638
- NYU Post - Graduate Med School $6,557
- Medical College of Wisconsin $6,506
- University of Texas Southwestern Medical School $4,995
- UC Davis Health School of Medicine $4,713
- Encore Borland Groover Clinical Research $4,017
- Jacksonville Center for Clinical Research $3,802
- The Methodist Hospital Research Institute $3,518
- New York University School of Medicine $3,347
- Cedars Sinai the Angeles Clinic and Research Institute $1,120
- Huron Gastroenterology $1,080
- Gastrointestinal Biosciences $1,080
- Houston Methodist Hospital Skilled Nursing Facility $990
- NYU Langone Gastroenterology and Hepatology Associates $990
- Liver Institute Northwest $720
- Baylor Scott and White All Saints Medical Center $317
- University of Pittsburgh $96
- Ut Southwest Medical Center $90
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.