The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Korea University Guro Hospital
Guro-dong, Guro-ku, Seoul, South Korea
Seoul National University
Yeongeon-dong, Jongno-Gu, Seoul, South Korea
Kangdong Sacred Heart Hospital
Gildong, Kangdong-Gu, Seoul, South Korea
Samsung Medical Center
Ilwon-dong, Kangnam-Gu, Seoul, South Korea
Efficacy: Change from baseline in HBV DNA (log10)
Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
Proportion of patients with hepatitis Be antigen (HBeAg) loss
Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
Biochemical improvement (e.g., ALT normalization)
Safety
Laboratory tests
Adverse Events
Vital Signs
Electrocardiogram (ECG)
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Yongdong Severance Hospital
Togok-tong, Kangnam-Gu, Seoul, South Korea
Asan Medical Center
P’ungnabi-dong, Songpa-Gu, Seoul, South Korea
Ewha Womans University Hospital
Mokdong, Yangchon-Gu, Seoul, South Korea
St. Mary's Hospital
Youido, Yougdungpo-Gu, Seoul, South Korea