Trials / Completed
CompletedNCT04563026
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment
A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 307 (actual)
- Sponsor
- Durect · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DUR-928 30 mg | IV infusion |
| DRUG | DUR-928 90 mg | IV infusion |
| DRUG | Placebo+ Standard of Care (SOC) | IV infusion |
Timeline
- Start date
- 2021-01-22
- Primary completion
- 2023-09-06
- Completion
- 2023-09-06
- First posted
- 2020-09-24
- Last updated
- 2024-09-05
Locations
68 sites across 6 countries: United States, Australia, Austria, Belgium, France, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04563026. Inclusion in this directory is not an endorsement.