Hepatitis C Clinical Trial
Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the
United States. Approximately one-third of patients with hepatitis C infection develop
cirrhosis of the liver, which can lead to liver failure or liver cancer. The current
treatment for hepatitis C infection in previously untreated patients is successful in only
about half of patients. There is no established therapy for non-responders.
This is a randomized, double-blinded, multicenter trial to determine the effectiveness of
thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk
compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without
cirrhosis who are non-responders to previous treatment with interferon or interferon plus
ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a
course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and
will be followed-up for a further 6 months after the end of therapy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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