At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 414 enrolled
Drug / intervention
c13 methacetin solution with breath analyzerdevice
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.
Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)
In Brief
A Phase 3 clinical trial evaluating c13 methacetin solution with breath analyzer for Chronic Liver Disease. Completed, enrolled 414 participants across 11 sites in 2 countries.
Detailed Summary
This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Liver Disease
CountriesIsrael, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedAug 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedAug 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.9 years ago
Interventions
c13 methacetin solution with breath analyzerdevice
Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver