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The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Change from baseline in HBV DNA (log10) | ||
| Safety: Laboratory tests, Adverse Events, Vital Signs, ECG |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | ||
| 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:
1)had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a >= 1 log10 decrease from baseline in HBV DNA at Week 48
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 | Guro-dong | Guro-ku, Seoul | South Korea | |||
| Seoul National University |
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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) |
| Yeongeon-dong |
| Jongno-Gu, Seoul |
| South Korea |
| Samsung Medical Center | Ilwon-dong | Kangnam-Gu, Seoul | South Korea |
| Yongdong Severance Hospital | Togok-tong | Kangnam-Gu, Seoul | South Korea |
| Asan Medical Center | P’ungnabi-dong | Songpa-Gu, Seoul | South Korea |
| Ewha Womans University Hospital | Mokdong | Yangchon-Gu, Seoul | South Korea |
| St. Mary's Hospital | Youido | Yougdungpo-Gu, Seoul | South Korea |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |