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NCT06016842 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
A Phase 3 study of Primary Biliary Cholangitis (PBC), sponsored by Ipsen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
- 20
- Study locations
NCT06016842 is a Phase 3 study of Primary Biliary Cholangitis (PBC) that is actively recruiting participants, run by Ipsen. The registered enrollment target is 276 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT06016842, a Phase 3 study of Primary Biliary Cholangitis (PBC), is actively recruiting participants, sponsored by Ipsen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
- 20
- Study locations
Study Summary
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to 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. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.
Conditions Studied
Interventions
- DRUG Elafibranor
- OTHER Matched 80 mg placebo
Study Locations (20)
California
- Southern California Research Center - Coronado
- Cedars-Sinai Medical Center - Los Angeles
- GastroIntestinal BioSciences - Los Angeles
- University of California Los Angeles - Los Angeles
- University of California Davis Medical Center - Sacramento
Colorado
- University of Colorado - Aurora
- Peak Gastroenterology Associates - Colorado Springs
- South Denver Gastroenterology, P.C. - Englewood
- Rocky Mountain Gastroenterology - Littleton
Florida
- University Of Miami School Of Medicine, Center For Liver Diseases - Miami
- Bolanos Clinical Research - Pembroke Pines
- International Center for Research - Tampa
Michigan
- University of Michigan Health System - Ann Arbor
- Huron Gastroenterology Associates - Center for Digestive Care - Ypsilanti
Arizona
- Arizona Liver Health - Tucson
Arkansas
- Arkansas Diagnostic Center, PA - Little Rock
Kansas
- University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic - Kansas City
Louisiana
- Louisiana Research Center, LLC - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06016842
The ClinicalTrials.gov registry entry for NCT06016842 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Biliary Cholangitis (PBC) appearing as the primary indexed condition, and to 2 interventions - of which Elafibranor is the first listed.
NCT06016842 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06016842 about?
NCT06016842 is a clinical study titled "A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis". The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage...
What is the current status of trial NCT06016842?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2023-08-31. Estimated completion is 2029-05-31.
What conditions does trial NCT06016842 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis (PBC).
What interventions are being tested in trial NCT06016842?
The interventions under investigation include: Elafibranor (DRUG), Matched 80 mg placebo (OTHER).
Who is sponsoring clinical trial NCT06016842?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06016842 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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