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Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
NCT04526665 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Elafibranor 80mg
Study Locations (20)
California
- Keck Medical Center of USC — Los Angeles
- Ruane Clinical Research Group Inc. — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- University of California, Davis Medical Center — Sacramento
- California Pacific Medical Center - Sutter Pacific Medical Foundation — San Francisco
New York
- UPMC Center for Liver Diseases — New Hyde Park
- NYU Langone Health / NYU Grossman School of Medicine — New York
- Columbia University Medical Center - Center for Liver Disease and Transplantation — New York
Colorado
- University of Colorado Denver and Hospital — Aurora
- South Denver Gastroenterology, P.C. — Englewood
Florida
- Encore Borland-Groover Clinical Research — Jacksonville
- Schiff Center for Liver Diseases/University of Miami — Miami
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center (BIDMC) — Boston
Arizona
- The Institute for Liver Health — Chandler
Connecticut
- Yale School of Medicine, Digestive Diseases — New Haven
Georgia
- Digestive Healthcare of Georgia — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04526665
The ClinicalTrials.gov registry entry for NCT04526665 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Biliary Cirrhosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04526665 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, New York, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04526665 about?
NCT04526665 is a clinical study titled "Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)". 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...
What is the current status of trial NCT04526665?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2020-09-24. Estimated completion is 2028-12-01.
What conditions does trial NCT04526665 study?
This clinical trial studies the following conditions: Primary Biliary Cirrhosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04526665?
The interventions under investigation include: Placebo (DRUG), Elafibranor 80mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04526665?
This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04526665 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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