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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, 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.
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, NKs are the main effector cells in early antiviral innate immune response.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 pDCs in the case of hepatitis and the function enhancement of NKs during Peg-IFN-α therapy. 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 explore whether the decline of HBsAg and HBeAg resulted in recovery of NKs function, or recovery of NKs function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage NKs function, and the loss of HBsAg and HBeAg led to recovery of NKs function.
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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 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 α-2a and Nucleoside Analogues Treatment | at baseline and at treatment week 12, 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| the change of ALT levels(U/L) |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33575322 | Derived | Cao W, Li M, Zhang L, Lu Y, Wu S, Shen G, Chang M, Liu R, Gao Y, Hao H, Hu L, Yi W, Pan CQ, Xie Y. The Characteristics of Natural Killer Cells in Chronic Hepatitis B Patients Who Received PEGylated-Interferon versus Entecavir Therapy. Biomed Res Int. 2021 Jan 25;2021:2178143. doi: 10.1155/2021/2178143. eCollection 2021. |
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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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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 |
| 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 |
| 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 |