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

Primary Purpose

Cirrhosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BreathID (Methacetin breath test)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Health System
  • Medical University of South Carolina
  • Virginia Commonwealth University Medical Center
  • Hadassah Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laboratory assay

Arm Description

Outcomes

Primary Outcome Measures

Mortality From Liver Failure
Patient dies of liver-related causes within 1 year of study entry

Secondary Outcome Measures

Liver Transplantation
Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation

Full Information

First Posted
July 2, 2010
Last Updated
April 29, 2014
Sponsor
Virginia Commonwealth University
Collaborators
Meridian Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01157845
Brief Title
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Meridian Bioscience, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laboratory assay
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BreathID (Methacetin breath test)
Other Intervention Name(s)
BreathID (Exalenz Bioscience LTD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality From Liver Failure
Description
Patient dies of liver-related causes within 1 year of study entry
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Liver Transplantation
Description
Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Being considered for placement or already on the liver transplantation waiting list Cirrhosis caused by any cause of chronic liver disease. Age > 18 years Exclusion criteria: Known or suspected hepatocellular carcinoma Prior TIPS placement Severe congestive heart failure Severe pulmonary hypertension Uncontrolled diabetes mellitus (HBA1C >9.5%) Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. Previous surgical bypass surgery for morbid obesity (BMI >45) Extensive small bowel resection Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs Women who are pregnant Patients who are allergic to acetaminophen/ paracetamol or any other related medications Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma. Patients that are taking hepatotoxin drugs Patient, based on the opinion of the investigator, should not be enrolled into this study Patient is unable or unwilling to sign informed consent. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard T Stravitz, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15679768
Citation
Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. doi: 10.1111/j.1365-2036.2005.02317.x.
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Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis

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