NCT03205345

Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression are events) in subjects with decompensated NASH cirrhosis.

Detailed description

The study treatment duration will be at least 48 weeks with study visits every 4 weeks up to Week 48 and every 8 weeks after Week 48. All subjects will continue treatment until the last subject in the study reaches 48 weeks in the study. At least 30% of subjects randomized should have baseline MELD score ≥15 and ≤20. For each subject, the study will consist of: * Screening period of up to 4 weeks * Randomized, double-blind treatment period of at least 48 weeks * A follow-up visit 2 weeks after completion of study drug treatment The duration of each subject's participation will be at least 54 weeks for those completing the entire study.

Conditions

• Decompensated Cirrhosis

Interventions

Type	Name	Description
DRUG	Emricasan (25 mg)	25 mg emricasan
DRUG	Emricasan (5 mg)	5 mg emricasan
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2017-06-28
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2017-07-02
• Last updated: 2019-03-19

Locations

76 sites across 1 country: United States

Regulatory

• FDA-regulated drug study