NCT03462576

Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17

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-6556-17

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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) \[ Time Frame: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks) \].

Conditions

• Decompensated Cirrhosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Methacetin Breath Test	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.
DRUG	Emricasan	Investigational drug for NASH treatment in Main Conatus protocol
DRUG	Placebo oral capsule	Placebo versus emricasan in Conatus NASH treatment trial

Timeline

• Start date: 2017-06-28
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2018-03-12
• Last updated: 2022-12-20
• Results posted: 2020-12-16

Locations

1 site across 1 country: United States