drugset / Trial / NCT03439189

Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14

NCT03439189 ↗

RandomizedParallel-groupTriple-blindDiagnostic

Summary

To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12 mmHg respectively, in patients with non-alcoholic steatohepatitis (NASH) during the course of treatment with Conatus's investigational product emricasan/placebo.

Timeline

Start
2016-08-28
Primary completion
2019-04-08
Completion
2019-05-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Emricasan Small molecule 5 mg Oral
Subject Emricasan Small molecule 25 mg Oral
Subject Emricasan Small molecule 50 mg Oral