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 for 48 weeks and follow up for 24 weeks.

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHB patients who had received NAs for more than 12 months. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive. Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL. Hepatitis B virus DNA not detectable(Roche Cobas). Exclusion Criteria: Patients with liver cirrhosis, Hepatocellular Carcinoma 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 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: PEG-IFN group<br>Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks. | Drug: Peginterferon alfa<br>* peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week<br>|
| No Intervention: NAs group<br>Patients do not need to change their NAs treatment. | |

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 negative. | 72 weeks | 
| HBsAg Seroconversion | Percentage of Participants with HBsAg negative and anti-HBsAg positive. | 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 alfa