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NCT04526665 · ClinicalTrials.gov registry record · Phase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
A Phase 3 study of Primary Biliary Cirrhosis, sponsored by Ipsen.
- Active
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
- 20
- Study locations
NCT04526665: Active Phase 3 study of Primary Biliary Cirrhosis, sponsored by Ipsen.
NCT04526665 is a Phase 3 study of Primary Biliary Cirrhosis that is active but no longer recruiting, run by Ipsen. The registered enrollment target is 161 participants, below the 1,419-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04526665, a Phase 3 study of Primary Biliary Cirrhosis, is active but no longer recruiting, sponsored by Ipsen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Cholestasis response was defined as alkaline phosphatase (ALP) \< 1.67 x upper limit of normal (ULN) and total bilirubin (TB) \<= ULN and ALP decrease from baseline \>= 15% at Week 52 and based on the composite strategy imputing non-response for participants who experienced intercurrent events (ICEs) (study treatment discontinuation or use of rescue therapy for PBC) prior to Week 52.
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 |
What the registry record for NCT04526665 still lists
NCT04526665 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 1,419-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (89% lower).
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.
NCT04526665 names 20 study sites across 11 states, led by California, New York, Colorado.
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.
What interventions are being tested in trial NCT04526665?
The interventions under investigation include: Placebo (DRUG), Elafibranor 80mg (DRUG).
Who is sponsoring clinical trial NCT04526665?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
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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