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This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Clevudine 30mg |
|
| 2 | Experimental | Clevudine 20mg+Adefovir dipivoxil 10mg |
|
| 3 | Experimental | Clevudine 20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine 30mg | Drug | Clevudine 30mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBV DNA levels < 300 copies/mL | 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| The change of HBV DNA form the baseline | (log copies/mL) | 24week, 48week, 96week |
| Proportion of patients with HBV DNA < 300 copies/mL | 48week, 96week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| Clevudine 20mg+Adefovir dipivoxil 10mg |
| Drug |
Clevudine 20mg+ Adefovir 10mg |
|
|
| Clevudine 20mg | Drug | Clevudine 20mg |
|
|
| Proportion of patients with ALT normalization | 24week, 48week, 96week |
| Proportion of patients with HBeAg loss and/or seroconversion | 96 Week |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C034935 | clevudine |
| C106812 | adefovir dipivoxil |
| C053001 | adefovir |
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