The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

Study Overview
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Brief Summary
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As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

Detailed Description
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In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.

Official Title
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The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: peginterferon alfa
* Drug: Nucleoside analogues


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHB patients who had received single NAs for more than 12 months. Hepatitis B e antigen (HBeAg)-negative. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL. Hepatitis B virus DNA <100 IU/mL. Exclusion Criteria: Patients with liver cirrhosis, Hepatocellular Carcinoma or AFP >2 ULN or other malignancies. Patients with other factors causing liver diseases. Pregnant and lactating women. Patients with concomitant HIV infection or congenital immune deficiency diseases. Patients with diabetes, autoimmune diseases. Patients with important organ dysfunctions. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.) Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. Patients with a previous use of IFN anti hepatitis B virus treatment or have NAs drug resistance. Patients who can't come back to clinic for follow-up on schedule.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1000 IU/mL and Hepatitis B virus DNA <100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up. | Drug: peginterferon alfa<br>* peginterferon alfa-2b or peginterferon alfa-2a<br>|
| Other: Control<br>Patients do not need to change their NAs treatment. | Drug: Nucleoside analogues<br>* Nucleoside analogues<br>* Other names: NAs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAg Clearance | Percentage of Participants with HBsAg <0.05 IU/mL. | 120 weeks | 
| HBsAg Seroconversion | Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive. | 120 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peginterferon alfa, Chronic Hepatitis B