Study on Clinical Program Optimization of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs)

Study Overview
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Brief Summary
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A multicenter, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml) to enter this study, and to compare the feasibility, effectiveness and safety treated with Pegylated Interferon α2b Continuous therapy or Pulse therapy in immune-controlled chronic hepatitis B patients.

Detailed Description
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Patients:chronic hepatitis B in the immune control phase (i.e. HBsAg positive, HBeAg negative, normal ALT and HBsAg≤1000IU/ml, HBV DNA≤2000IU/ml). The study patients were divided into two groups.Group A (PEG IFN α- 2b continuous group): PEG IFN was injected subcutaneously once a week from the first day of baseline α- 2b 180 μg. The total course of treatment should not exceed 96 weeks.Group B (PEG IFN α- 2b pulse group): from the first day of baseline, PEG IFN was injected subcutaneously α- 2b 180 μg. Every 8 weeks of injection, stop for 4 weeks, and conduct it periodically.Two groups at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72weeks, 84 weeks, 96 weeks and the 12th and 24th weeks after drug withdrawal, and corresponding examinations were carried out at each follow-up.Check and record adverse events and concomitant medication in detail, and evaluate the compliance of subjects; Blood samples were retained and transported to the laboratory for HBV at baseline, 24 weeks, 48weeks, 72, 96, and 12 and 24 after drug withdrawal.DNA quantification and detection of hepatitis B virus markers.The efficacy and safety were evaluated after the study.

Official Title
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The Efficacy and Safety of IHCs Treated With Pegylated Interferon α2b Based on Pulse Theray or Sequential Therapy

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Behavioral: continuous treatment
* Behavioral: pulse therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 65 years, both male and female (including 18 and 65 years old); HBV DNA≤2000 IU/ml and HBeAg negative; HBsAg positive for more than 6 months, and HBsAg≤1000 IU/ml; ALT≤ULN at screening (discontinue liver-protecting enzyme-lowering drugs for at least 2 weeks); A negative urine or serum pregnancy test (for women of childbearing age) within 24 hours before the first dose; B-ultrasound or fibroscan suggest no liver cirrhosis; Willing to accept treatment and sign informed consent. Exclusion Criteria: Participants with other hepatotropic viruses or human immunodeficiency virus co-infection; other chronic non-viral liver diseases or decompensated liver diseases; tumours; drug abuse; severe psychiatric disease; uncontrolled thyroid disease or diabetes; pregnancy or lactation.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (continuous treatment group)<br>The treatment period is 12 weeks as a treatment unit, starting from the first day of baseline, subcutaneous injection of Peg-IFNα-2b 180μg once a week, the total treatment course does not exceed 96 weeks. During treatment, when any efficacy check point reaches the disappearance of HBsAg with or without the appearance of HBsAb, at least 2 treatment units of consolidation therapy are given and then the drug is discontinued. Observed for 24 weeks after treatment. | Behavioral: continuous treatment<br>* The treatment period is 12 weeks as a treatment unit, starting from the first day of baseline, subcutaneous injection of Peg-IFN α-2b 180μg once a week, or every 8 weeks of injection, 4 weeks off, periodically, the total treatment course does not exceed 96 weeks.<br>|
| Experimental: Group B (pulse therapy group)<br>The treatment period is 12 weeks as a treatment unit. From the first day of baseline, subcutaneous injection of Peg-IFNα-2b 180 μg, every injection for 8 weeks, stop for 4 weeks, periodically, the total treatment course does not exceed 96 weeks. During treatment, when any efficacy check point reaches the disappearance of HBsAg with or without the appearance of HBsAb, at least 2 treatment units of consolidation therapy are given and then the drug is discontinued. Observed for 24 weeks after treatment. | Behavioral: pulse therapy<br>* pulse therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of HBsAg decrease at 48 weeks | Decreasing level and difference of HBsAg in different treatment groups after 48 week treatment | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAg clearance at the end of 96 weeks of treatment | To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 96 week treatment | 96 weeks | 
| The decreasing extent of HBsAg level at 96 weeks | Decreasing level and difference of HBsAg in different treatment groups after 96 week treatment | 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inactive hepatitis B virus carriers, Pegylated Interferon α2b, Continuous treatment, pulse treatment