Trials / Completed
CompletedNCT02854631
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selonsertib | 18 mg tablet administered orally once daily |
| DRUG | Prednisolone | 40 mg (4 x 10 mg tablets) administered orally once daily |
| DRUG | Placebo | Selonsertib placebo tablet administered orally once daily |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-02-16
- Completion
- 2018-05-31
- First posted
- 2016-08-03
- Last updated
- 2019-02-06
- Results posted
- 2019-02-06
Locations
44 sites across 7 countries: United States, Austria, Belgium, Canada, France, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02854631. Inclusion in this directory is not an endorsement.