The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
Time frame: At follow-up Week 24 (SVR24) following 48 weeks of treatment
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities
Time frame: From Day 1 to end of Week 48 on-treatment
Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms
Time frame: From Day 1 to end of Week 48 on-treatment
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