BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Chronic Liver Disease Clinical Trial

— MBT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736840
• Other study ID #: HIS-EX-408
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: December 2022
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Fibrosis
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer Sheba
Israel	Carmel Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health Sytem	Detroit	Michigan
United States	Inova Helath System	Falls Church	Virginia
United States	St Luke's Episcopal Hospital, Baylor College of Medicine	Houston	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)	"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.	Study day 1 after a 1 hour test
Secondary	AUC of ROC (Area Under Receiver Operating Characteristic Curve)	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.	At study day 1 after 1 hour test