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The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral activity- Change from baseline in HBV DNA (log10) | ||
| Safety- Laboratory tests, Adverse Events, Vital Signs, ECG |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral activity- 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) | ||
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Inclusion Criteria:
Exclusion Criteria:
(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
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| Name | Affiliation | Role |
|---|---|---|
| Hyo Suk Lee, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Guro-gu | South Korea | |||
| Seoul National University Hospital |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C034935 | clevudine |
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| Serology: Proportion of patients with HBeAg loss,Seroconversion rate (HBeAg loss and anti-HBe gain) |
| Seoul |
| Jongno-Gu |
| South Korea |
| Yongdong Severance Hospital | Dogok-dong, Kangnam-gu | Seoul | South Korea |
| Samsung Medical Center | Ilwon-dong, Songpa-gu | Seoul | South Korea |
| Ehwa Womans University Mokdong Hospital | Mok-dong, Yangcheon-gu | Seoul | South Korea |
| Seoul Asan Medical Center | Pungnap-dong, Kangnam-gu | Seoul | South Korea |
| Asan Medical Center | P’ungnabi-dong | Songpa-Gu, Seoul | South Korea |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |