At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 104 enrolled
Drug / intervention
Selonsertib +2 moredrug
Likely dose
Selonsertib 18 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Selonsertib, Prednisolone, and 1 other intervention for Alcoholic Hepatitis (AH). Completed, enrolled 104 participants across 44 sites in 7 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholic Hepatitis (AH)
CountriesAustria, Belgium, Canada, France, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionFeb 2018
Study CompletionMay 2018
TodayJul 2026
First PostedAug 3, 2016
Enrollment StartSep 1, 2016
Primary CompletionFeb 16, 2018
Study CompletionMay 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.9 years ago
Interventions
Selonsertibdrug
18 mg tablet administered orally once daily
Prednisolonedrug
40 mg (4 x 10 mg tablets) administered orally once daily
Placebodrug
Selonsertib placebo tablet administered orally once daily