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

NCT03439189 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2022-12-20

Study results available
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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.

Conditions

  • NASH - Nonalcoholic Steatohepatitis
  • Cirrhosis
  • Portal Hypertension

Interventions

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

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
2016-08-28
Primary Completion
2019-04-08
Completion
2019-05-13

Countries

  • France

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 NCT03439189 on ClinicalTrials.gov