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 1 who are IFNa treatment naive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,331
900 mcg or 1200mcg every two week for 48 weeks
180 mcg once a week for 48 weeks
1000 mg/day(for subjects \<75kg) or 1200 mg/day (for subjects =,\> 75kg)
Sustained virologic response (SVR)
Time frame: Week 72
Rapid virologic response
Time frame: Week 4
Early virologic response
Time frame: Week 12
Undetectable HCV RNA
Time frame: Week 24 and Week 48
Normalization of ALT (a liver enzyme)
Time frame: Week 48
Quality of life evaluation
Time frame: throughout the entire study
Safety assessments (physical exams, AE reporting, lab testing/analysis, HADS and Immunogenicity testing)
Time frame: Throughout the entire study
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