The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL). In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Kyusyu Region
Fukuoka, Japan
Chugoku Region
Okayama, Japan
Kinki Region
Osaka, Japan
Hokkaido Region
Sapporo, Japan
Kanto Region
Tokyo, Japan
Sustained viral response as undetectable level of HCV-RNA
Time frame: week 24 from the end of treatment
Biochemical response as normal level of ALT
Time frame: week 24 from the end of treatment
Viral response as undetectable level of HCV-RNA
Time frame: at the end of treatment
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Tokai Region
Yamanashi, Japan