NCT02960204

Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Histogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• Portal Hypertension
• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Emricasan
DRUG	Placebo

Timeline

• Start date: 2016-10-17
• Primary completion: 2018-10-02
• Completion: 2019-04-08
• First posted: 2016-11-09
• Last updated: 2022-02-11
• Results posted: 2022-01-14

Locations

37 sites across 3 countries: United States, Germany, Spain

Regulatory

• FDA-regulated drug study