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

NCT03462576 · Status: TERMINATED · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2022-12-20

Study results available
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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.

Conditions

  • Decompensated Cirrhosis

Interventions

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

Sponsors & Collaborators

  • Conatus Pharmaceuticals Inc.

    collaborator INDUSTRY

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2019-07-15
Completion
2019-07-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462576 on ClinicalTrials.gov