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临床试验/NCT02275221
NCT02275221招募中不适用

Investigation and Elucidation of Host Immune Responses in Patients With Hepatitic B and C Virus Infection

Mid and South Essex NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
To investigate whether changes in immune cell response for in-patients with Hepatitis B or C can be used to develop better treatment regimes

研究概览

简要总结

Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, the investigators hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression.

详细描述

Hepatitis B virus (HBV) and C (HCV) are the leading causes of liver disease worldwide. Approximately 400 million people worldwide are chronically infected with HBV world wide and it is estimated that 3% of the entire world population is infected with HCV and yet there is still no vaccine available.

Chronic viral hepatitis infection is primarily the result of a complex interaction between the virus and an impaired host immune response. The host immune response has a unique role in HBV and HCV infection because it contributes not only to viral control clinical recovery and protective immunity but also to the development of chronic hepatitis and liver cirrhosis. There is currently no cure for most patients who already have chronic HBV and HCV infection and a proportion of patients fail to respond to current antiviral regimens. Since these patient remain at risk for disease progression it is crucial to investigate host immune responses and to determine the precise role of these responses in disease outcome.

Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, we hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression. This information can be utilised to develop more effective treatment regimens in order to reduce the current global burden of these diseases.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic Hepatitis B patients At all stages of infection Treatment naive and previously treated Longitudinal samples from patients treated with antiviral agents and interferon
  • Chronic Hepatitis C patients All genotypes - treatment naive and previously treated Longitudinal samples from patients treated with interferon and STATIC therapy

排除标准

  • Coinfection with HIV Coinfection with hepatitis delta Excessive alcohol use Autoimmune liver disease Metabolic liver disease

结局指标

主要结局

To investigate whether changes in immune cell response for in-patients with Hepatitis B or C can be used to develop better treatment regimes

时间窗: on average 4 weeks

The principle aim of this study is to investigate exactly how patients; immune cells interact with hepatitis B and C virus after becoming infected. By understanding how the immune cells interact with the virus it will be possible to use this information to develop better treatment regimens for these patients

次要结局

  • Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis B during their inpatient stay(on average 4 weeks)
  • Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis C during their inpatient stay(on average 4 weels)
  • Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis C during their inpatient stay(on average 4 weeks)
  • Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis B during their inpatient stay(on average 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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