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NCT03124108 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
A Phase 2 study, sponsored by Genfit.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT03124108: Completed Phase 2 study, sponsored by Genfit.
NCT03124108 is a Phase 2 study that has completed, run by Genfit. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03124108, a Phase 2 study, has completed, sponsored by Genfit.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.
Interventions
- DRUG Placebo
- DRUG Elafibranor 80 mg
- DRUG Elafibranor 120 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-04-05 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 2 |
What the finished NCT03124108 record still lists
NCT03124108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03124108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03124108 about?
NCT03124108 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid". 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).
What is the current status of trial NCT03124108?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2017-04-05. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT03124108?
The interventions under investigation include: Placebo (DRUG), Elafibranor 80 mg (DRUG), Elafibranor 120 mg (DRUG).
Who is sponsoring clinical trial NCT03124108?
This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03124108's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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