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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | |||
| Purified hepatitis B surface antigen | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral Activity: Proportion of patients with HBeAg loss | Screening, Day1(predose), every 4 weeks during treatment period(48weeks) | |
| Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG | Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heon Young Lee, MD. PhD. | Chungnam National University Hospital | Principal Investigator |
| Hyeon Woong Yang, MD. PhD. | Eulji University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dankook University Hospital | Anseo-dong, Cheonan Si | Chungcheongnam-do | South Korea | |||
| Soon Chun Hyang University Cheonan Hospital |
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| Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48 |
| 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 | 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 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C034935 | clevudine |
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