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This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Clevudine 30mg |
|
| 2 | Active Comparator | Entecavir 0.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | 30mg,QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Intrahepatic cccDNA reduction from baseline | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBV DNA below LOD by real-time PCR | day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) | |
| Reduction of HBV DNA level from baseline | day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 9 Sites | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C034935 | clevudine |
| C413685 | entecavir |
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| Entecavir |
| Drug |
0.5mg QD |
|
|
| ALT normalization | day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) |
| Reduction of sAg titer from baseline | day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) |
| Proportion of maintaining sustained effect | every 8 weeks during follow-up period(48weeks) |
| 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 |