Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

Study Overview
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Brief Summary
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For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Detailed Description
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For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Official Title
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The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Entecavir
* Drug: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 50 years old HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment Treated by entacavir for 48 weeks with HBeAg seroconversion Exclusion Criteria: Pregnant women Decompensated liver disease Combination infection of HCV, HAV, or HEV Combination infection of HIV Any contraindication of interferon α

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: entecavir<br>patients continue to use entecavir | Drug: Entecavir<br>* entecavir 0.5mg per day<br>* Other names: Baraclude;|
| Experimental: peg-interferon<br>patients switch to sequential peg-interferon α-2a | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a 180ug per week<br>* Other names: Pagasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBeAg sericonversion rate |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBeAg loss rate |  | 72 weeks | 
| HBeAg quantification dynamic change |  | 72 weeks | 
| HBsAg loss rate |  | 72 weeks | 
| HBsAg seroconversion rate |  | 72 weeks | 
| HBsAg quantification dynamic change |  | 72 weeks | 
| ALT normalization rate |  | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, sequential peg-interferon-2a to entecavir