Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00444002
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00444002
Study Brief:
Protocol Section:
NCT00444002