The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Efficacy:
Antiviral activity (change from baseline in HBV DNA (log 10))
Safety:
Laboratory tests
Adverse Events
Vital signs
ECG
Efficacy
Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay)
Biochemical improvement (e.g. ALT normalization )
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St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, South Korea
Pusan Paik Hospital
Gaegeum-dong, Busan, South Korea
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu, Seoul, South Korea
Keimyumg University Dongsan Medical Center
Jung-gu, Daegu, South Korea
Chonnam National University Hospital
Hak-1-dong, Dong-gu, Gwangju-si, South Korea
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
Wonkwang University Hospital
Iksan, Jeollabuk-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Seoul National University Hospital
Seoul, Jongno-Gu, South Korea
Inha University Hospital
Sinhŭng-dong, Jung-gu, Incheon, South Korea
...and 20 more locations