Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: June 16, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Diagnostic
Condition: Chronic Liver Disease
Intervention: Device: c13 methacetin solution with breath analyzer

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
414 subjects were collected in 11 sites; 8 in the United states and 3 in Israel. Recruitment began in August 2008 and was completed Sep 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4 sites, 1 in Israel and 3 in the United States recruited most of the subjects. Patients with chronic liver disease and recent biopsies performed or planned were approached. Exclusion criteria focused mostly on issues that would affect accuracy of breath test.

Reporting Groups
  Description
CLD (Chronic Liver Disease) Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)

Participant Flow:   Overall Study
    CLD (Chronic Liver Disease)  
STARTED     414  
COMPLETED     401 [1]
NOT COMPLETED     13  
Lost to Follow-up                 13  
[1] 9 subjects-no biopsy results, 2-no breath test, 2 no biopsy results and no complete breath test



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CLD (Chronic Liver Disease) Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)

Baseline Measures
    CLD (Chronic Liver Disease)  
Number of Participants  
[units: participants]
  414  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     374  
>=65 years     39  
Age  
[units: years]
Mean ± Standard Deviation
  51.3  ± 10.9  
Gender  
[units: participants]
 
Female     178  
Male     236  
Region of Enrollment  
[units: participants]
 
United States     327  
Israel     87  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)   [ Time Frame: Study day 1 after a 1 hour test ]

2.  Secondary:   AUC of ROC (Area Under Receiver Operating Characteristic Curve)   [ Time Frame: At study day 1 after 1 hour test ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Technical problems caused the termination of 2 subjects who did not complete breath test. Liver biopsy, 1 patient refused and others had signs of HCC thus disqualified.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Manager
Organization: Exalenz Bioscience
phone: 972-8-9737500 ext 513
e-mail: avrahamh@exalenz.com


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