Facilitated By

San Antonio Medical Foundation

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

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active

This is a multicenter, double-blind, randomized, placebo-controlled, dose-response study to evaluate the safety and efficacy of emricasan in improving portal hypertension in subjects with NASH cirrhosis and severe portal hypertension (defined as hepatic venous pressure gradient (HVPG) ?12 mmHg). Subjects can have compensated (at least 60% of subjects but no more than 75%) or decompensated cirrhosis with no more than 1 prior significant decompensating event and must be currently clinically stable on stable standard therapy [2] (see Inclusion/Exclusion criteria). Randomization will be stratified by compensated vs. decompensated status at baseline as well as use of non-selective beta-blockers (NSBB) or not. Subjects who are otherwise eligible will undergo the HVPG procedure as the last qualifying procedure prior to Day 1.

Collaborative Project
Clinical Care
Infectious Disease
The appearance of name-brand products in this article does not constitute endorsement by Brooke Army Medical Center, the U.S. Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of Defense, or the U.S. Government of the information, products, or services contained therein.