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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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2032-07-15 |
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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, categorized as an unspecified phase. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 154-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (175% higher). 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 appearing as the primary indexed condition, and to 0 interventions.
NCT06447168 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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