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RECRUITING

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

NCT06447168 · View on ClinicalTrials.gov ↗

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).

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

Sponsor

Ipsen

205 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06447168

The ClinicalTrials.gov registry entry for NCT06447168 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06447168 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Texas, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT06447168?

This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial