Chronic Hepatitis B Infection Clinical Trial
Official title:
The Changes of Natural Killer 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, NKs are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of NKs frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of NKs function, or Peg IFN - alpha enhanced NKs 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 |
---|---|
Beijing Ditan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the changes of Natural Killer Cells | the changes of NK%,CD56bri/NK%,CD56dim/NK%,IFNAR2+NK%,IFNAR2MFI,NKp46+/NK%,NKp46dim/NK%,NKp46high/NK%, NKp46MFI,and NKp46ABC will be measured by flow cytometry during Pegylated Interferon a-2a and Nucleoside Analogues Treatment | 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 and HBV DNA levels and liver function | 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 HBV markers and HBV DNA levels and liver function | 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 HBV markers and HBV DNA levels and liver function | at baseline and at treatment 12, 24, 36, 48 weeks |
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