Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion After Interferon Therapy

Study Overview
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Brief Summary
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Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients. However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur in some patients who achieved HBeAg seronconversion by interferon treatment. In this study, the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg seronconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed.

Detailed Description
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HBeAg positive chronic hepatitis B patients achieved HBeAg seronconversion by interferon treatment will be enrolled and observed for 156 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is sustained viral response, and secondary endpoints is HBV DNA reaction and clinical relapse defined as virla relapse with abnormal ALT during observation period.

Official Title
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Sustained Viral Response and Clincal Relapse in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion by Interferon Therapy

Conditions
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Chronic Hepatitis B

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who achieved HBeAg seroconversion by interferon 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained viral response | The serum HBV DNA load and HBeAg level will be tested every 3 month for 156 weeks after completed treatment in patients who achieved HBeAg seroconversion by interferon treatment. The rate of sustained viral response defined HBV DNA maintaining undetectable during observation period will be evaluated. | 156 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA reaction | HBV DNA reaction was defined as HBV DNA load reverse back to detectable during observation period. | 156 weeks | 
| clinical relapse | clinical relapse is defined as virla relapse with abnormal ALT during observation period | 156 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBeAg positive, interferon, peginterferon, HBeAg seroconversion, sustained viral response, relapse