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

April 29, 2014 updated by: Virginia Commonwealth University

Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Being considered for placement or already on the liver transplantation waiting list
  2. Cirrhosis caused by any cause of chronic liver disease.
  3. Age > 18 years

Exclusion criteria:

  1. Known or suspected hepatocellular carcinoma
  2. Prior TIPS placement
  3. Severe congestive heart failure
  4. Severe pulmonary hypertension
  5. Uncontrolled diabetes mellitus (HBA1C >9.5%)
  6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
  7. Previous surgical bypass surgery for morbid obesity (BMI >45)
  8. Extensive small bowel resection
  9. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs
  10. Women who are pregnant
  11. Patients who are allergic to acetaminophen/ paracetamol or any other related medications
  12. Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
  13. Patients that are taking hepatotoxin drugs
  14. Patient, based on the opinion of the investigator, should not be enrolled into this study
  15. Patient is unable or unwilling to sign informed consent.
  16. Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laboratory assay
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.
Other Names:
  • BreathID (Exalenz Bioscience LTD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality From Liver Failure
Time Frame: 1 year
Patient dies of liver-related causes within 1 year of study entry
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Transplantation
Time Frame: 1 year
Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Meridian Bioscience, Inc.

Investigators

  • Principal Investigator: Richard T Stravitz, MD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (ESTIMATE)

July 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VirginiaCU HM12041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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