NCT03439189

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

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)

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-14 (NCT02960204).The IDN-6556-14 study is a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial in subjects with non-alcoholic steatohepatitis (NASH) cirrhosis and severe portal hypertension. As one of the Conatus' study exploratory objectives, this companion protocol is designed to assess whether emricasan compared to placebo improves liver metabolic function at Weeks 24 and 48 as assessed by the methacetin breath test (at select sites), if relevant.

Conditions

• NASH - Nonalcoholic Steatohepatitis
• Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Methacetin Breath Test	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.
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: 2016-08-28
• Primary completion: 2019-04-08
• Completion: 2019-05-13
• First posted: 2018-02-20
• Last updated: 2022-12-20
• Results posted: 2020-09-04

Locations

1 site across 1 country: France