Status:
COMPLETED
Oxidative Stress and Fatty Acids in Hepatitis C
Lead Sponsor:
Johane Allard
Collaborating Sponsors:
Canadian Association of Gastroenterology
Conditions:
Hepatitis C
Hepatic Steatosis
Eligibility:
All Genders
18+ years
Brief Summary
Hepatitis C virus infection (HCV) is a major health concern in Canada and worldwide. Chronic HCV can cause progressive liver damage leading to inflammation, scarring and, in some cases, cirrhosis or l...
Detailed Description
Hypothesis: Patients with Hepatitis C and steatosis are more oxidatively stressed than those without steatosis. This is associated with 1) increased liver lipid peroxides and cytokines (TNF-alpha, TGF...
Eligibility Criteria
Inclusion
- Male and female patients, age \>18 y
- Established hepatitis C infection as confirmed by positive serology and positive hepatitis C RNA in serum
- Convincing evidence of negligible alcohol consumption (\<20g of ethanol per day) obtained from a detailed history, confirmed by at least one close relative
- Absence of any other possible cause for liver dysfunction.
- Undergoing routing liver biopsy (usually pre-treatment)
Exclusion
- Findings highly suggestive of liver disease of other etiology (e.g. other viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis and genetic liver diseases such as hemochromatosis, alpha-1 antitrypsin deficiency, Wilsons disease and biliary obstruction)
- Anticipated need for liver transplantation in one year or complications of liver disease such as recurrent variceal bleeding, spontaneous porto- systemic encephalopathy, resistant ascites or bacterial peritonitis
- Concurrent medical illnesses contraindicating a liver biopsy (history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reasons judged by the hepatologist to contraindicate a percutaneous liver biopsy)
- Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, sulfasalazine or cloxacillin) in the 6 months prior to entry
- Antioxidant vitamin or n-3 supplementation, ursodeoxycholic acid or any other experimental drug in the 6 months prior to study entry
- Pregnant or lactating
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00444002
Start Date
July 1 2005
End Date
July 1 2010
Last Update
January 10 2014
Active Locations (1)
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1
University Health Network (Toronto General Hospital & Toronto Western Hospital)
Toronto, Ontario, Canada