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临床试验/NCT03147157
NCT03147157尚未招募不适用

The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen

The First Hospital of Jilin University0 个研究点目标入组 120 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Possibility of tacrolimus regimen guided by HLA matching rate

研究概览

简要总结

The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

详细描述

Liver transplantation is the most effective treatment for end-stage liver disease, yet long term survival is limited by acute and chronic rejection reaction and adverse reactions caused by immune inhibitors. However, effective guideline of immune inhibitors regimen after liver transplantation is lacking. Human major histocompatibility antigens (HLA) is crucial in renal transplantation, while the role in liver transplantation is unclear. It is reported that HLA matching was closely related to the occurrence of graft versus host disease (GVHD) after liver transplantation. And by reducing or removing the immune inhibitors can change the course of illness, improve prognosis, at the same time conduce to induce immune tolerance. Therefore, the investigators have the reason to believe that HLA matching rate has closely association with postoperative immune status of patients after liver transplantation, which may guide immune inhibitors regimen. The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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
否

入选标准

  • •patients signed informed consent,patients with good compliance

排除标准

  • •autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation

研究组 & 干预措施

research group,low MR group

Experimental

tacrolimus regimen guided by HLA matching rate

干预措施: tacrolimus regimen guided by HLA matching rate (Other)

observation group,low MR group

No Intervention

tacrolimus regimen is applied according to clinical experience

research group,middle MR group

Experimental

tacrolimus regimen guided by HLA matching rate

干预措施: tacrolimus regimen guided by HLA matching rate (Other)

observation group,middle MR group

No Intervention

tacrolimus regimen is applied according to clinical experience

research group,high MR group

Experimental

tacrolimus regimen guided by HLA matching rate

干预措施: tacrolimus regimen guided by HLA matching rate (Other)

observation group,high MR group

No Intervention

tacrolimus regimen is applied according to clinical experience

结局指标

主要结局

Possibility of tacrolimus regimen guided by HLA matching rate

时间窗: 3 months

Changes of liver function and incidence of acute rejection early after liver transplantation

次要结局

  • Occurrence rate of GVHD(5 years)
  • Occurrence time of adverse reactions caused by immune inhibitors(5 years)
  • Patient survival rate(1-year,3-year and 5-year)
  • Degree of adverse reactions caused by immune inhibitors(5 years)

研究者

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

Guoyue Lv

Vice President

The First Hospital of Jilin University

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