A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Public ClinicalTrials.gov record NCT06447168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06447168
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 424 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2024 (Actual)
- Primary completion
- Jul 15, 2032 (Estimated)
- Completion
- Jul 15, 2032 (Estimated)
- Last update posted
- Oct 1, 2026
2024 – 2032
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92118 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| South Denver Gastroenterology,P.C. | Englewood | Colorado | 80113 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Schiff Center for Liver Diseases - University of Miami | Miami | Florida | 33136 | — |
| Beth Israel Deaconess Medical Center, Liver Research Center | Boston | Massachusetts | 02215 | — |
| Virtua Center for Liver Disease - Cherry Hill | Cherry Hill | New Jersey | 08034 | — |
| Northwell Health Inc, Center for Liver Disease and Transplantation | Manhasset | New York | 11030 | — |
| UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Liver Center of Texas | Dallas | Texas | 75234 | — |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | — |
| Texas Digestive Specialists | McAllen | Texas | 78504 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| Virginia Commonwealth University Medical Center - West Hospital | Richmond | Virginia | 23298 | — |
| Velocity Clinical Research | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06447168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06447168 live on ClinicalTrials.gov.