Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
2630
Trial Sponsor
Clinical Trial Start Date
October 17, 2016
0Primary Completion Date
October 2, 2018
0Study Completion Date
April 8, 2019
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
Placebo0
Emricasan0
Interventional Trial Phase
Phase 20
Official Name
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 Hypertension0
Last Updated
February 11, 2022
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Triple0
Masked Party
Outcomes Assessor0
Investigator0
Participant0
Study 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.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.