Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

Study Overview
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Brief Summary
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The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.

Detailed Description
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HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment would be randomize enrolled into two groups, in Interventional group, patients will receive entecavir combine with peginterferon alpha 2a treatment for 48 weeks and followed 24 weeks. Patients in control group will be continue treated only by peginterferon alpha 2a for 48 weeks and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of combined therapy were evaluated by the rate of sustained viral response after 48 weeks treatment and 24 weeks follow up compared with control group.

Official Title
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Efficacies of Entecavir Add on HBeAg Negative Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 3 Months of Peginterferon Alpha 2a Treatment

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Entecavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon a-2a treatment Exclusion Criteria: Active consumption of alcohol and/or drugs Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus History of autoimmune hepatitis Psychiatric disease Evidence of neoplastic diseases of the liver

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: entecavir with PEG-IFN a-2a<br>After enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks and 24 weeks of follow up after treatment. | Drug: Entecavir<br>* After enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks and 24 weeks of follow-up after treatment.<br>|
| No Intervention: control group<br>In this group, patients will be continue treated only by PEG-IFN a-2a for 48 weeks after enrolled and receive 24 weeks of follow up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of sustained virual response | sustained viral response was defined as serum HBV DNA load was undetectable at the end of treatment and 24 weeks of follow-up. | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of HBsAg loss during treatment course and at the end of follow-up | HBsAg loss defined as HBsAg level ≤0.05 IU/ml | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis B, peginterferon, sustained viral response, entecavir, HBeAg