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This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | HB-110 2mg, 4mg or 8mg combined with Adefovir |
|
| II | Active Comparator | Adefovir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a mixed plasmid DNA (HB-110) | Genetic | HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and clinical laboratory abnormalities | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity | 24, 28, 32, 42, 44, and 48 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Seung-kyu Yoon, M.D. | The Department of Gastroenterology at Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangnam St. Mary's Hospital | Seoul | 137-701 | 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 |
|---|---|
| C053001 | adefovir |
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| Adefovir | Drug | Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48. |
|
| 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 |