Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
Public ClinicalTrials.gov record NCT03124108. 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
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).
Study identification
- NCT ID
- NCT03124108
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Apr 4, 2017
- Primary completion
- Oct 30, 2018
- Completion
- Oct 30, 2018
- Last update posted
- Sep 23, 2019
2017 – 2018
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | — |
| Schiff Center for Liver Diseases | Miami | Florida | 33136 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Piedmont Research Institute | Atlanta | Georgia | 30309 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Northwell Health Institution | Manhasset | New York | 11030 | — |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
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 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03124108, 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 Sep 23, 2019 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03124108 live on ClinicalTrials.gov.