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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 is a Phase 2 study that has completed, run by Genfit. The registered enrollment target is 45 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03124108
The ClinicalTrials.gov registry entry for NCT03124108 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genfit, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03124108 reports 0 study locations.
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.
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