This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
9 Sites
Seoul, South Korea
Intrahepatic cccDNA reduction from baseline
Time frame: week 48
Proportion of patients with HBV DNA below LOD by real-time PCR
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Reduction of HBV DNA level from baseline
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
ALT normalization
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Reduction of sAg titer from baseline
Time frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)
Proportion of maintaining sustained effect
Time frame: every 8 weeks during follow-up period(48weeks)
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