This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
933
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
800mg/day for 24 weeks
Sustained virologic response (SVR)
Time frame: Week 48
Rapid virologic response
Time frame: Week 4
Early virologic response
Time frame: Week 12
Undetectable HCV RNA
Time frame: Week 24
Normalization of ALT (a liver enzyme)
Time frame: Week 48
Quality of life evaluation
Time frame: Week 48
Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)
Time frame: Througout the entire treatment period
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