Status:
TERMINATED
BreathID Multi-center HCV Liver Breath Test Study
Lead Sponsor:
Meridian Bioscience, Inc.
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Baylor College of Medicine
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (\>2 in META...
Detailed Description
Percutaneous liver biopsy has been utilized for decades to assess the severity of chronic HCV liver disease. During this procedure a core sample of liver is obtained and examined histologically for th...
Eligibility Criteria
Inclusion
- i. Patients with a confirmed diagnosis of Chronic HCV only : ii. Patients for whom a liver biopsy has been performed within the last 90 days or who will undergo a liver biopsy within the time frame of the study.
Exclusion
- i. Severe congestive heart failure. ii. Severe pulmonary hypertension. iii.Chronic renal insufficiency defined by a serum creatinine above the limits of normal. iv. Uncontrolled diabetes mellitus (need definition).v.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. vi.Proven or suspected hepatocellular carcinoma. vii. Previous surgical bypass surgery for morbid obesity viii.Extensive small bowel resection. ix.Patients currently receiving total parenteral nutrition x.Recipients of any organ transplant. xi.Other co-existent liver disease.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00350714
Start Date
July 1 2006
End Date
February 1 2007
Last Update
December 20 2022
Active Locations (5)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
2
Baylor College of Medicine
Houston, Texas, United States, 77030
3
U.S. Dept. of Veteran Affairs, Hunter Holmes McGuire Medical Center
Richmond, Virginia, United States, 23249-0001
4
Virginia Commonwealth Univeristy
Richmond, Virginia, United States, 23284