A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Dankook University Hospital
Anseo-dong, Cheonan Si, Chungcheongnam-do, South Korea
Soon Chun Hyang University Cheonan Hospital
Bongmyeong-dong, Cheonan Si, Chungcheongnam-do, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daeheung-dong, Jung-gu, Daejeon, South Korea
Chungnam National University Hospital
Antiviral Activity: Proportion of patients with HBeAg loss
Time frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG
Time frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48
Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion
Time frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a
Time frame: Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48
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Daesa-dong, Jung-gu, Daejeon, South Korea
Eulji University Hospital
Dunsan 2-dong, Seo-gu, Daejeon, South Korea
Konyang University Hospital
Gasuwon-dong, Seo-gu,, Daejeon, South Korea
Chungbuk National University Hospital
Gaesin-dong, Cheongju Si Heungdeok-gu, North Chungcheong, South Korea