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

August 14, 2008
February 15, 2012
August 2008
September 2009   (final data collection date for primary outcome measure)
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.
Sensitivity of the BreathID "Hepatic Impairment Score" (HIS) in diagnosis of cirrhosis greater than or equal to 0.80 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00736840 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Chronic Liver Disease
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
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
Intervention: Device: c13 methacetin solution with breath analyzer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
414
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00736840
HIS-EX-408
Yes
Exalenz Bioscience LTD.
Exalenz Bioscience LTD.
Not Provided
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
Exalenz Bioscience LTD.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP