NCT03439189

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

Completed Results posted Last updated 20 December 2022

What this trial tests

trial testing Methacetin Breath Test in NASH - Nonalcoholic Steatohepatitis in 343 participants. Completed in 13 May 2019.

Timeline

28 August 2016

Primary endpoint
8 April 2019

13 May 2019

Quick facts

Lead sponsor	Meridian Bioscience, Inc.
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	diagnostic
Enrollment	343
Start date	28 August 2016
Primary completion	8 April 2019
Estimated completion	13 May 2019
Sites	1 location across France

Drugs / interventions tested

• Methacetin Breath Test
• Emricasan — full drug profile →
• Placebo oral capsule

Conditions studied

• NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
• Cirrhosis — all drugs for Cirrhosis →
• Portal Hypertension — all drugs for Portal Hypertension →

Sponsor

Meridian Bioscience, Inc. — full company profile →

Who can join

18 and older, any sex, with NASH - Nonalcoholic Steatohepatitis or Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Matched Clinically Significant Portal Hypertension Based on Hepatic Venous Pressure Gradient (HVPG) and Methacetin Breath Test (MBT) Primary · 1 hour for MBT related to assessment of this diagnostic primary outcome assesses during screening

Binary diagnosis of clinically significant portal hypertension (CSPH) as determined by HVPG, defined as HVPG ≥ 10mmHg and by the MBT derived from an algorithm developed under other Exalenz clinical studies

Group	Value	95% CI
Subjects With CSPH	190

Number of Matched Subjects With Significant Portal Hypertension (Defined as HVPG>=12mmHg) Based on HVPG and MBT Secondary · 1 hour for MBT for assessment of this diagnostic secondary outcome assessed during screening

Binary diagnosis of HVPG\>=12mmHg and by the MBT derived from an algorithm developed under other Exalenz clinical studies

Group	Value	95% CI
Number of Subjects With SPH	182

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected for a duration of approximately 1 year to observe the effect of the treatment. Additional MBTs after 24 and 48 weeks were performed to enable Conatus to assess the ability of MBT to identify improvement in liver function due to treatment, if relevant. Each MBT duration is 1 hour. The subsequent MBTs were not relevant to companion protocol primary and secondary efficacy diagnostic endpoints listed above, but additional safety information regarding these MBTs was collected.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ACLD With NASH

Serious: 0/343 (0%)

Deaths: 0/343

Other adverse events (2 terms — click to expand)

Reaction	System	ACLD With NASH
Cramps	Musculoskeletal and connective tissue disorders	—
Diarrhea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03439189 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.