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临床试验/NCT01311947
NCT01311947已完成不适用

Relation of Hepatitis B Virus Mutants and the Therapeutic Effect of Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2011年3月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
Therapeutic response to Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

研究概览

简要总结

In order to clarify the association between HBV mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations. Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally, statistical analysis will be done to elucidate whether the mutations of preS/S gene and BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.

详细描述

Hepatitis B virus (HBV) infection is a serious worldwide health issue. Approximately 400 million people worldwide are chronic hepatitis B (CHB) patients. Currently, two therapeutic methods can be used to treat CHB. One is the nucleos(t)ide analogues, the other is the interferon alfa. Interferon alfa acts mainly by enhancing the immune system and directly inhibits the virus to a limited extent. It is known that mutations at preS, S, basal core promoter, precore and core gene are associated with an increased risk of HCC. However, it remains to be clarified as to the relation between HBV mutations and the therapeutic responses to interferon treatment. In order to clarify the association between HBV mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations. Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally, statistical analysis will be done to elucidate whether the mutations of preS/S gene and BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HBeAg-positive chronic hepatitis B patients on Peginterferon therapy

排除标准

  • HBeAg-negative chronic hepatitis B patients HBeAg-positive chronic hepatitis B patients on other kinds of therapy

结局指标

主要结局

Therapeutic response to Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

时间窗: 24 weeks after the end of 24 weeks of Peginterferon alfa-2a treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheng-Yuan Peng

Director of Division of Hepatogastreoenterology

China Medical University Hospital

研究点 (1)

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