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临床试验/NCT04244383
NCT04244383Unknown4 期

Expression of Inflammasomes in HCV Patients Before and After Treatment

Assiut University0 个研究点目标入组 50 人开始时间: 2020年1月最近更新:
适应症

试验速览

阶段
4 期
入组人数
50
主要终点
changes in the exprssion level of inflammasomes

研究概览

简要总结

Hepatitis C virus has been identified a quarter of a decade ago as a leading cause of chronic viral hepatitis that can lead to cirrhosis and hepatocellular carcinoma. Only a minority of patients can clear the virus spontaneously during acute infection. Elimination of HCV during acute infection correlates with a rapid induction of innate and a delayed induction of adaptive immune responses. The majority of patients is unable to clear the virus and develops viral persistence despite the ongoing innate and adaptive immune response. The virus usually develops several strategies to escape these immune responses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Chronic hepatitis C virus patients.
  • Patients do not start treatment protocol.

排除标准

  • Pregnant women.
  • Hepato-cellular carcinoma patients.
  • Autoimmune disease patients.
  • Patients with liver cirrhosis.
  • Patients who refuse to participate in the study

结局指标

主要结局

changes in the exprssion level of inflammasomes

时间窗: 6 monthes

observe the changes in the exprssion level of inflammasomes in the selected chronic HCV patients before treatment with Sofosbuvir 400 mg and Daclatasvir 60 mg daily for 12 weeks and after sustained virological response at 12 weeks following the end of treatment (SVR12).

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

Aya Fergany

princible inverstigator

Assiut University

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