Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (NCT04526665)
A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid
🩺 Plain-English Summary (8th-Grade Level)
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 study drug) is better than placebo (a dummy treatment) at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also evaluate the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itchy skin (pruritus) and tiredness (fatigue). This study has two main parts: Part 1 will compare a daily dose of elafibranor to a daily dose of placebo and will last between a minimum of one year and a maximum of two years. Part 2, all participants will receive elafibranor for a period of up to 5 years or until the total treatment duration (part 1 and part 2) reaches 6 years, whichever occurs first.
Who can join: Review the eligibility criteria below.
Location: The Institute for Liver Health — Chandler, Arizona
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (115 Sites)
Showing the first 25 of 115 sites.
- The Institute for Liver Health — Chandler, Arizona
- Keck Medical Center of USC — Los Angeles, California
- Ruane Clinical Research Group Inc. — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- University of California, Davis Medical Center — Sacramento, California
- California Pacific Medical Center - Sutter Pacific Medical Foundation — San Francisco, California
- University of Colorado Denver and Hospital — Aurora, Colorado
- South Denver Gastroenterology, P.C. — Englewood, Colorado
- Yale School of Medicine, Digestive Diseases — New Haven, Connecticut
- Encore Borland-Groover Clinical Research — Jacksonville, Florida
- Schiff Center for Liver Diseases/University of Miami — Miami, Florida
- Digestive Healthcare of Georgia — Atlanta, Georgia
- University of Kansas Medical Center — Kansas City, Kansas
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts
- Henry Ford Health System — Novi, Michigan
- Saint Louis University — St Louis, Missouri
- UPMC Center for Liver Diseases — New Hyde Park, New York
- NYU Langone Health / NYU Grossman School of Medicine — New York, New York
- Columbia University Medical Center - Center for Liver Disease and Transplantation — New York, New York
- The New York-Presbyterian Hospital, David H. Koch Center — New York, New York
- Duke University Medical Center — Durham, North Carolina
- Carolinas Centre for Liver disease/ Atrium Health — Huntersville, North Carolina
- Consultants for Clinical Research — Cincinnati, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Primary Biliary Cirrhosis
- Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC) — Little Rock, Arkansas
Explore by condition: All Primary Biliary Cirrhosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.