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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, 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 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. |
|
| control group | No Intervention | patients who were untreated ever in immune-active phase took Nucleoside Analogues for maintenance treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Alfa-2a | Drug | patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group. |
| Measure | Description | Time Frame |
|---|---|---|
| the changes of cytokines | the changes of cytokines levels will be measured by Luminex test after Pegylated Interferon α-2a and entecavir((ETV) Treatment 24 weeks. | after treatment 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Xie, MD | Contact | 8610-84322489 | xieyao00120184@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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| 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 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |