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临床试验/NCT00683748
NCT00683748Unknown不适用

Monitoring Cellular Immunity After Kidney and Liver Transplantation

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
T cell reactivity to viral antigens

研究概览

简要总结

After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • All patients undergoing kidney or liver transplantation at the Karolinska University Hospital

排除标准

  • Abscence of informed consent

结局指标

主要结局

T cell reactivity to viral antigens

时间窗: Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation

次要结局

未报告次要终点

研究者

发起方
Karolinska University Hospital
申办方类型
Other

研究点 (1)

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