Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis

NCT01157845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2014-05-16

Study results available
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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.

Conditions

  • Cirrhosis

Interventions

DEVICE

BreathID (Methacetin breath test)

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.

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    collaborator INDUSTRY
  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Richard T Stravitz, MD · Virginia Commonwealth University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Israel

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 NCT01157845 on ClinicalTrials.gov