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NCT03394924 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
A Phase 2 study, sponsored by Enanta Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT03394924: Completed Phase 2 study, sponsored by Enanta Pharmaceuticals.
NCT03394924 is a Phase 2 study that has completed, run by Enanta Pharmaceuticals. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03394924, a Phase 2 study, has completed, sponsored by Enanta Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
Primary Outcome
Percent change was calculated as \[(ALP at Week 12 - ALP at Baseline)/ALP at Baseline\] \*100. The participant was considered to have successfully achieved a 20% reduction in ALP if the result was ≤-20. The participant was considered to have successfully achieved ALP normalization if ALP was abnormal at Baseline and normal at Week 12.
Interventions
- DRUG Placebo
- DRUG EDP-305 1 mg
- DRUG EDP-305 2.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2017-12-27 |
| Est. Completion | 2020-01-16 |
| Phase | Phase 2 |
What the finished NCT03394924 record still lists
NCT03394924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03394924 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03394924 about?
NCT03394924 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis". A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
What is the current status of trial NCT03394924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2017-12-27. Estimated completion is 2020-01-16.
What interventions are being tested in trial NCT03394924?
The interventions under investigation include: Placebo (DRUG), EDP-305 1 mg (DRUG), EDP-305 2.5 mg (DRUG).
Who is sponsoring clinical trial NCT03394924?
This trial is sponsored by Enanta Pharmaceuticals, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03394924's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 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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