Status:
COMPLETED
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
Lead Sponsor:
Meridian Bioscience, Inc.
Conditions:
Chronic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 chroni...
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 Criteria
Inclusion
- Age \>18 with chronic liver disease
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT00736840
Start Date
August 1 2008
End Date
September 1 2009
Last Update
January 12 2023
Active Locations (11)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Henry Ford Health Sytem
Detroit, Michigan, United States, 48202
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104