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For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA is undetectable (<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | At the twelfth week of interferon α treatment, HBV DNA is detectable(>1000 copies/ml), or HBeAg is still positive. And nucleoside analogue is added for 12 weeks. |
|
| 2 | Active Comparator | At the twelfth week of interferon α treatment, HBV DNA is detectable (>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added. |
|
| 3 | Active Comparator | At the twelfth week of interferon α treatment, HBV DNA is undetectable (<1000 copies/ml), or HBeAg is negative. And interferon is continued for another 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon α plus nucleoside analogue | Drug | Standard dose of interferon is used for 12 weeks. On 12th week of treatment, HBV DNA is still detectable (>1000 copies/ml), or HBeAg is still positive. And lamivudine is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue. |
| Measure | Description | Time Frame |
|---|---|---|
| HBeAg seroconversion rate | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA loss rate | 3-6 months | |
| HBsAg loss rate | 3-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| huang zhanlian, doctor | Contact | +86013580584031 |
| Name | Affiliation | Role |
|---|---|---|
| Gao zhiliang, Doctor | The Third Affliated Hospital of Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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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 |
|---|---|
| D009705 | Nucleosides |
| ID | Term |
|---|---|
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| interferon α | Drug | Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is still detectable (>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added. |
|
| interferon α | Drug | Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is undetectable, or HBeAg is negative. And interferon is continued alone for another 9 months. |
|
| 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 |