Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Public ClinicalTrials.gov record NCT04526665. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04526665
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 161 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 24, 2020 (Actual)
- Primary completion
- Jun 1, 2023 (Actual)
- Completion
- Dec 1, 2028 (Estimated)
- Last update posted
- Sep 1, 2026
2020 – 2028
United States locations
- U.S. sites
- 46
- U.S. states
- 20
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Institute for Liver Health | Chandler | Arizona | 85224 | — |
| Keck Medical Center of USC | Los Angeles | California | 90033 | — |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| California Pacific Medical Center - Sutter Pacific Medical Foundation | San Francisco | California | 94109 | — |
| University of Colorado Denver and Hospital | Aurora | Colorado | 840045 | — |
| South Denver Gastroenterology, P.C. | Englewood | Colorado | 80113 | — |
| Yale School of Medicine, Digestive Diseases | New Haven | Connecticut | 06510 | — |
| Encore Borland-Groover Clinical Research | Jacksonville | Florida | 32256 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| UPMC Center for Liver Diseases | New Hyde Park | New York | 11042-11114 | — |
| NYU Langone Health / NYU Grossman School of Medicine | New York | New York | 10016 | — |
| Columbia University Medical Center - Center for Liver Disease and Transplantation | New York | New York | 10032 | — |
| The New York-Presbyterian Hospital, David H. Koch Center | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Carolinas Centre for Liver disease/ Atrium Health | Huntersville | North Carolina | 28078 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45249 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210-1240 | — |
| Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina- College of Medicine | Charleston | South Carolina | 29425 | — |
| Vanderbilt Digestive Disease Center | Nashville | Tennessee | 37232 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Liver Center of Texas, PLLC | Dallas | Texas | 75234 | — |
| The University of Texas Southwestern Medical Center-IDS Aston Pharmacy | Dallas | Texas | 75390-8575 | — |
| Texas Digestive Disease Consultants dba GI Alliance | Fort Worth | Texas | 76104 | — |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | — |
| St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research | Houston | Texas | 77030 | — |
| American Research Corporation | San Antonio | Texas | 78215 | — |
| Gastro health & Nutrition-Victoria | Victoria | Texas | 77904 | — |
| Intermountain Medical Center - Transplant Services | Murray | Utah | 84107 | — |
| University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition | Salt Lake City | Utah | 84132 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads | Newport News | Virginia | 23602 | — |
| Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| Virginia Commonwealth University Clinical Research Services Unit (CRSU) | Richmond | Virginia | 23298 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04526665, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04526665 live on ClinicalTrials.gov.