A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
clevudine 30 mg qd
KoreaUniversity Guro Hospital
Seoul, South Korea
Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR
Time frame: Screening, day1,every 12 weeks during treatment period(96weeks)
Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation
Time frame: Screening, day1, every 12 weeks during treatment period(96 weeks)
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