Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B

Study Overview
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Brief Summary
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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.

Official Title
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Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: interferon α plus nucleoside analogue
* Drug: interferon α
* Drug: interferon α


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBsAg posive for 6 months HBeAg positive, and HBeAb negative HBV DNA>1.0×E5 copies/ml ALT>80 u/L within 3 months Exclusion Criteria: pregnant women conbination infection of HCV, HAV, or HEV conbination infection of HIV any contraindication of interferon α

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: interferon α plus nucleoside analogue<br>* 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.<br>|
| Active Comparator: 2<br>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. | Drug: interferon α<br>* 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.<br>|
| Active Comparator: 3<br>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. | Drug: interferon α<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBeAg seroconversion rate |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA loss rate |  | 3-6 months | 
| HBsAg loss rate |  | 3-6 months |