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NCT03432260 · ClinicalTrials.gov registry record · Phase 2
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
A Phase 2 study, sponsored by Durect.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT03432260: Completed Phase 2 study, sponsored by Durect.
NCT03432260 is a Phase 2 study that has completed, run by Durect. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03432260, a Phase 2 study, has completed, sponsored by Durect.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).
Primary Outcome
The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score \>0.45 predicts a higher risk of death and the recommendation to stop steroid administration. Lille Score = Exp(-R)/(1 + Exp(-R)) Where: R = \[3.19 - (0.101 x Age in years)\] + (1.47 x Albumin in g/dL)
Interventions
- DRUG DUR-928 30 mg
- DRUG DUR-928 90 mg
- DRUG DUR-928 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2019-09-09 |
| Phase | Phase 2 |
What the finished NCT03432260 record still lists
NCT03432260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which DUR-928 30 mg is the first listed.
NCT03432260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03432260 about?
NCT03432260 is a clinical study titled "A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis". This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).
What is the current status of trial NCT03432260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2018-04-18. Estimated completion is 2019-09-09.
What interventions are being tested in trial NCT03432260?
The interventions under investigation include: DUR-928 30 mg (DRUG), DUR-928 90 mg (DRUG), DUR-928 150 mg (DRUG).
Who is sponsoring clinical trial NCT03432260?
This trial is sponsored by Durect, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03432260's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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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