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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 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.

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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.

Conditions Studied

Primary Biliary Cirrhosis

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

FieldValue
Enrollment Target 161 participants
Start Date 2020-09-24
Est. Completion 2028-12-01
Phase Phase 3

Sponsor

Ipsen

85 total trials

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What the Registry Record Tells You About NCT04526665

The ClinicalTrials.gov registry entry for NCT04526665 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,419-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (89% lower). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.