Chronic Hepatitis B Infection
Conditions
Keywords
chronic hepatitis B, hepatitis B virus, Cytokines, Pegylated Interferon α-2a, Nucleoside Analogues
Brief summary
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, cytokines played a vital role. This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in the secretion of cytokines.
Detailed description
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, cytokines including Fit-3L, IFN-alpha2, IFN-gama, IL-10, IL-17A,IL-2, IL-6, TNF-alpha, TGF-beta1, TGF-beta2,TGF-beta3, played a vital role.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 might be related to the increase of cytokine secretion in the case of hepatitis and during Peg-IFN-α therapy.This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to clarify whether Peg-IFN-α therapy led to the secretion of cytokines.
Interventions
DRUGPeginterferon Alfa-2a
patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group.
Sponsors
Beijing Ditan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the changes of cytokines | after treatment 24 weeks | the changes of cytokines levels will be measured by Luminex test after Pegylated Interferon α-2a and entecavir((ETV) Treatment 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the change of HBVDNA levels (IU/ML) | afte treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by HBV DNA levels |
| the change of ALT levels(U/L) | afte treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by ALT levels |
| the change of AST levels(U/L) | afte treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by AST levels |
| the change of HBsAg levels (IU/ML) | afte treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by HBsAg levels |
| the change of HBeAg levels (IU/ML) | afte treatment 48 weeks | the curative effect of antiviral therapy will be evaluated by HBeAg levels |
Countries
China
Contacts
Primary ContactYao Xie, MD
Outcome results
None listed