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

This study has been completed.
Sponsor:
Collaborator:
Exalenz Bioscience LTD.
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01157845
First received: July 2, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Cirrhosis
Device: BreathID (Methacetin breath test)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Mortality From Liver Failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patient dies of liver-related causes within 1 year of study entry


Secondary Outcome Measures:
  • Liver Transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation


Enrollment: 165
Study Start Date: March 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BreathID (Exalenz Bioscience LTD)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157845

Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Virginia Commonwealth University
Exalenz Bioscience LTD.
Investigators
Principal Investigator: Richard T Stravitz, MD Virginia Commonwealth University
  More Information

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01157845     History of Changes
Other Study ID Numbers: VirginiaCU HM12041
Study First Received: July 2, 2010
Results First Received: January 17, 2014
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014