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

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ClinicalTrials.gov Identifier: NCT01157845
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : March 4, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cirrhosis Device: BreathID (Methacetin breath test) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: BreathID (Exalenz Bioscience LTD)


Outcome Measures

Primary Outcome Measures :
  1. Mortality From Liver Failure [ Time Frame: 1 year ]
    Patient dies of liver-related causes within 1 year of study entry


Secondary Outcome Measures :
  1. Liver Transplantation [ Time Frame: 1 year ]
    Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 7, 2010    Key Record Dates
Results First Posted: March 4, 2014
Last Update Posted: May 16, 2014
Last Verified: April 2014

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