CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 165 enrolled
Drug / intervention
BreathID (Methacetin breath test)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01157845
NCT01157845Phase 3Completed
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Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation

Virginia Commonwealth University·interventional·Posted Jul 7, 2010·Updated May 16, 2014

In Brief

A Phase 3 clinical trial evaluating BreathID (Methacetin breath test) for Cirrhosis. Completed, enrolled 165 participants across 4 sites in 2 countries.

Detailed Summary

The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis
CountriesIsrael, United States
CollaboratorsMeridian Bioscience, Inc.

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2010
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.0 years ago

Interventions

BreathID (Methacetin breath test)device

13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.