Pegaferon and Ribavirin for Hepatitis C
Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
Lead SponsorIsfahan University
StatusCompleted No Results Posted
Intervention/Treatmentribavirin interferon alpha-2b ...
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4
Inclusion Criteria: Chronic hepatitis C Age between 15 and 65 Exclusion Criteria: previous treatment for chronic hepatitis C co-infection with human immunodeficiency virus or hepatitis B virus major thalassemia or hemophilia active drug user being treated for major depression or psychosis decompensated cirrhosis serum creatinine > 1.5 mg/dL solid organ transplant untreated thyroid disease uncontrolled diabetes mellitus uncontrolled autoimmune disease advanced cardiac or pulmonary disease. planning to become pregnant in the next 1.5 years patients with inadequate contraception not consenting to the study