NCT00736840

BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

Conditions

• Chronic Liver Disease

Interventions

Type	Name	Description
DEVICE	c13 methacetin solution with breath analyzer	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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-08-18
• Last updated: 2023-01-12
• Results posted: 2012-03-16

Locations

11 sites across 2 countries: United States, Israel