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BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis (MBT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT00736840
First received: August 14, 2008
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.


Condition Intervention Phase
Chronic Liver Disease
 Device: c13 methacetin solution with breath analyzer
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Exalenz Bioscience LTD.:

Primary Outcome Measures:
  • Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS) [ Time Frame: Study day 1 after a 1 hour test ] [ Designated as safety issue: No ]
    "Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard.


Secondary Outcome Measures:
  • AUC of ROC (Area Under Receiver Operating Characteristic Curve) [ Time Frame: At study day 1 after 1 hour test ] [ Designated as safety issue: No ]
    The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.


Enrollment: 414
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CLD (chronic liver disease)
Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver
 Device: c13 methacetin solution with breath analyzer
Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver

Detailed Description:

Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

  Eligibility

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

Inclusion Criteria:

  • Age >18 with chronic liver disease

Exclusion Criteria:

  • Patients that are taking hepatotoxin drug.
  • Patient with severe congestive heart failure
  • Patient with severe pulmonary hypertension
  • Patient with uncontrolled diabetes mellitus
  • Patient with previous surgical bypass surgery for morbid obesity
  • Patient with extensive small bowel resection
  • Patient currently receiving total parenteral nutrition
  • Patient is a recipients of any organ transplant
  • Patients that received any anti-viral treatment within the past year
  • Women who are pregnant
  • Patient allergic to acetaminophen (such as Tylenol or any other related medications)
  • Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
  • Patients unable to sign informed consent
  • Patients that based on the opinion of the investigator should not be enrolled into this study
  • 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: NCT00736840

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Michigan
Henry Ford Health Sytem
Detroit, Michigan, United States, 48202
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29435
United States, Texas
St Luke's Episcopal Hospital, Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Inova Helath System
Falls Church, Virginia, United States, 22042
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-0341
Israel
Soroka Medical Center
Beer Sheba, Israel
Carmel Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel, 93000
Sponsors and Collaborators
Exalenz Bioscience LTD.
Investigators
Principal Investigator: Stuart Gordon, MD Henry Ford Health System
Principal Investigator: Adrian Rueben, MD Medical University of South Carolina
Principal Investigator: Gadi Lalazar, MD Hadassah Medical Center
Principal Investigator: Arun Sanyal, MD Virginia Commonwealth University
Principal Investigator: Fred Poordad, MD Cedars Sinai Health System
Principal Investigator: K Rajender Reddy, MD University of Pennsylvania Health System
Principal Investigator: Zobair Younossi, MD Inova Health System
Principal Investigator: Arthur McCullough, MD The Cleveland Clinic
Principal Investigator: John Vierling, MD St. Luke's Episcopal Hospital, Baylor College of Medicine
Principal Investigator: Alexander Fich, MD Soroka Medical Center
Principal Investigator: Eli Zuckerman, MD Carmel Medical Center
  More Information

No publications provided

Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT00736840     History of Changes
Other Study ID Numbers: HIS-EX-408
Study First Received: August 14, 2008
Results First Received: June 16, 2011
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Exalenz Bioscience LTD.:
Methacetin
Breath
Test
Cirrhosis

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

ClinicalTrials.gov processed this record on May 19, 2013