Chronic Hepatitis B Infection Clinical Trial
Official title:
The Changes of CD4+T Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B
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, CD4+T Cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD4+T Cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function, or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Ditan hospital,Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Yao Xie |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the changes of CD4+T Cells | the changes of CD4+T cells%, CD62L+T cells%, CD62L-T cells%, CD62L+/ CD62L-, CD69+CD4+T cells%, CD69MFI, CD69ABC, IFN-AR2+CD4+T cells%, IFNAR2MFI, IFNAR2ABC will be measured by flow cytometry during Pegylated Interferon a-2a and Nucleoside Analogues treatment every 3 months. | at baseline and at treatment week 12, 24. | |
Secondary | the change of HBVDNA levels (IU/ML) | the curative effect of antiviral therapy will be evaluated by HBV markers | at baseline and at treatment 12, 24, 36, 48 weeks | |
Secondary | the change of ALT levels(U/L) | the curative effect of antiviral therapy will be evaluated by ALT levels | at baseline and at treatment 12, 24, 36, 48 weeks | |
Secondary | the change of AST levels(U/L) | the curative effect of antiviral therapy will be evaluated by AST levels | at baseline and at treatment 12, 24, 36, 48 weeks |
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