This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-17.The IDN-6556-17 study is a Phase 2, multicenter, double-blind, placebo-controlled trial of Emricasan in subjects with decompensated non-alcoholic steatohepatitis (NASH) cirrhosis.
The protocol is intended to validate the ability of the MBT to predict deterioration by 48 weeks for all subjects, and at later time points for those followed longer, for subjects with decompensated NASH cirrhosis in the placebo treatment arm of Conatus' study IDN-6556-17. As one of the Conatus' study secondary objectives, this companion protocol is designed to assess improvement in liver metabolic function as measured by Methacetin Breath Test (MBT) \[ Time Frame: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks) \].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
199
A breath analyzer will be used to measure changes in carbon 12 to carbon13 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
Florida Digestive Health Specialists Research Institute
Lakewood Rch, Florida, United States
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 5.5%/hour. The data was collected and analyzed agnostic to the intervention.
Time frame: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
Number of Subjects Experiencing a High Risk Event Based on a 7.5 %/Hour Cut-off
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 7.5%/hour.The data was collected and analyzed agnostic to the intervention.
Time frame: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
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