This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
180μg(s.c.)/week for 48 weeks
90μg(s.c.)/week for 48 weeks
600, 800, or 1,000 mg X 2(p.o.)/day
Chugoku
Chugoku, Japan
Hokkaido Region
Hokkaido, Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Kyusyu Region
Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
Time frame: week 24 from the end of treatment
Biochemical response (normalization of serum alanine aminotransferase activity)
Time frame: at the end of treatment and week 24 form the end of treatment
Virological response (HCV-RNA < 50 IU per milliliter)
Time frame: at the end of treatment and week 24 form the end of treatment
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Kyusyu, Japan
Shikoku Region
Shikoku, Japan
Tohoku Region
Tōhoku, Japan
Tokai Region
Tōkai, Japan