The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Korea University Guro Hospital
Guro-dong, Guro-ku, Seoul, South Korea
Seoul National University
Yeongeon-dong, Jongno-Gu, Seoul, South Korea
Samsung Medical Center
Ilwon-dong, Kangnam-Gu, Seoul, South Korea
Yongdong Severance Hospital
Togok-tong, Kangnam-Gu, Seoul, South Korea
Efficacy: Change from baseline in HBV DNA (log10)
Safety: Laboratory tests, Adverse Events, Vital Signs, ECG
Efficacy
Proportion of patients with HBV DNA below the assay Limit of Detection (4,700 copies/mL by Digene Hybrid Capture II)
Biochemical improvement (ALT normalization)
Serology Proportion of patients with HBeAg loss Seroconversion rate (HBeAg loss and anti-HBe gain)
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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