At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 263 enrolled
Drug / intervention
Emricasan +1 moredrug
Likely dose
Not stated in 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension
In Brief
A Phase 2 clinical trial evaluating Emricasan and Placebo for Cirrhosis and 2 related conditions. Completed, enrolled 263 participants across 37 sites in 3 countries.
Detailed Summary
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedNov 2016
Primary CompletionOct 2018
Study CompletionApr 2019
TodayJul 2026
First PostedNov 9, 2016
Enrollment StartOct 17, 2016
Primary CompletionOct 2, 2018
Study CompletionApr 8, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.6 years ago
Interventions
Emricasandrug
Placebodrug