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NCT06447168 · ClinicalTrials.gov registry record

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

A clinical trial of Primary Biliary Cholangitis, sponsored by Ipsen.

Recruiting
Registry status
424
Enrollment target
20
Study locations

NCT06447168: Recruiting study of Primary Biliary Cholangitis, sponsored by Ipsen.

NCT06447168 is a study of Primary Biliary Cholangitis that is actively recruiting participants, run by Ipsen. The registered enrollment target is 424 participants, above the 154-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (175% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06447168, a study of Primary Biliary Cholangitis, is actively recruiting participants, sponsored by Ipsen.

RECRUITING
Registry status
424 participants
Enrollment target
20
Study locations

Study Summary

This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).

Primary Outcome

Defined as alkaline phosphatase (ALP) \<1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.

Conditions Studied

Primary Biliary Cholangitis

Study Locations (20)

California

  • Southern California Research Center - Coronado
  • Cedars-Sinai Medical Center - Los Angeles
  • University of California Davis Medical Center - Sacramento

Texas

  • Liver Center of Texas - Dallas
  • Baylor College of Medicine - Advanced Liver Therapies - Houston
  • Gastro health & Nutrition - Katy

Virginia

  • Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond - Richmond
  • Virginia Commonwealth University Medical Center - West Hospital - Richmond

Colorado

  • South Denver Gastroenterology,P.C. - Englewood

Connecticut

  • Yale University School of Medicine - New Haven

Florida

  • Schiff Center for Liver Diseases - University of Miami - Miami

Massachusetts

  • Beth Israel Deaconess Medical Center, Liver Research Center - Boston

New Jersey

  • Virtua Center for Liver Disease - Cherry Hill - Cherry Hill

Trial Details

FieldValue
Enrollment Target 424 participants
Start Date 2024-10-14
Est. Completion 2032-07-15
Ipsen

85 total trials

What NCT06447168 shows while recruiting

NCT06447168 is an observational study that tracks outcomes without assigning an intervention. The registered 424 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (175% higher).

The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 0 interventions.

NCT06447168 names 20 study sites across 15 states, led by California, Texas, Virginia.

Frequently Asked Questions

What is clinical trial NCT06447168 about?

NCT06447168 is a clinical study titled "A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment". This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirr...

What is the current status of trial NCT06447168?

This trial is currently recruiting. The enrollment target is 424 participants. The study started on 2024-10-14. Estimated completion is 2032-07-15.

What conditions does trial NCT06447168 study?

This clinical trial studies the following conditions: Primary Biliary Cholangitis.

Who is sponsoring clinical trial NCT06447168?

This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06447168 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Primary Biliary Cholangitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06447168's enrollment target sits among peer trials

424 1st of 8 higher than 8 of 8 other Primary Biliary Cholangitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Primary Biliary Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06447168

Source: ClinicalTrials.gov NCT06447168, the US trial registry maintained by the National Library of Medicine. NCT06447168 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.