At a glance
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Companion Protocol for the ¹³C-Methacetin Breath Test Using the BreathID® MCS System for Conatus Phase 2 Study of Emricasan, an Oral Caspase Inhibitor, Under Protocol IDN-6556-14 (NCT02960204)
In Brief
A clinical study evaluating Methacetin Breath Test, Emricasan, and 1 other intervention for NASH - Nonalcoholic Steatohepatitis and 2 related conditions. Completed, enrolled 343 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A breath analyzer will be used to measure changes in carbon-12 to carbon-13 ratio as a result of metabolism of the Methacetin substrate before and after treatment.
Investigational drug for NASH treatment in Main Conatus protocol
Placebo versus emricasan in Conatus NASH treatment trial