The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Study Overview
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Brief Summary
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Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role in immune. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

Detailed Description
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Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, Treg cells play an important role in immune regulation.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of Treg cells in the case of hepatitis and the function enhancement of Treg cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

Official Title
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The Changes of Treg Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B

Conditions
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Chronic Hepatitis B Infection

Intervention / Treatment
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* Drug: Peginterferon Alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled. 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: 20 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>patients who were untreated ever in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly till 48 weeks. | Drug: Peginterferon Alfa-2a<br>* patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group<br>* Other names: Peg-IFN-α;|
| No Intervention: control group<br>patients who were untreated ever in immune-active phase took Nucleoside Analogues for maintenance treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of Treg Cells | Treg Cells will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24weeks. | after treatment 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of HBVDNA levels (IU/ML) | the curative effect of antiviral therapy will be evaluated by HBV DNA levels | afte treatment 48 weeks | 
| the change of ALT levels(U/L) | the curative effect of antiviral therapy will be evaluated by ALT levels | afte treatment 48 weeks | 
| the change of AST levels(U/L) | the curative effect of antiviral therapy will be evaluated by AST levels | afte treatment 48 weeks | 
| the change of HBsAg levels (IU/ML) | the curative effect of antiviral therapy will be evaluated by HBsAg levels | afte treatment 48 weeks | 
| the change of HBeAg levels (IU/ML) | the curative effect of antiviral therapy will be evaluated by HBeAg levels | afte treatment 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis B, hepatitis B virus, Treg Cells, Pegylated Interferon α-2a, Nucleoside Analogues