Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
The Influence of Genetic and Clinical Factors on Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
研究概览
地位
条件
详细说明
A great number of studies had found significant correlation between tacrolimus pharmacokinetics and gene polymorphism. However, previous studies on the correlation between genetic factors and clinical outcome were controversial. Furthermore, most studies focused on single genetic polymorphism and clinical outcome, and very limited studies took multiple genetic factors and clinical factors into account.
This is a retrospective study. Eligible patients were those who had signed informed consent for genetic study in previous research projects ( IRB approval number：201512005RINC and 201612023RIND ). The present study will collect laboratory data, concurrent medications, and therapeutic drug monitoring (TDM) data. Patient survival, graft survival, acute rejection and tacrolimus-associated adverse events will be assessed.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Taipei、台湾
- National Taiwan University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Eligible patients were those who had signed informed consent for genetic study in our previous research projects.
Inclusion Criteria of the Previous Study:
- patients who underwent living-donor liver transplantation during January 2008 to December 2017
- at the age of 20-65
- with tacrolimus-based immunosuppression after liver transplant for at least 6 months.
Exclusion Criteria of the Previous Study :
- retransplantation
- multi-organ transplantation
- human immunodeficiency virus (HIV) positive.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of patients with biopsy proven acute rejection (BPAR)
大体时间：up to 12 months after liver transplantation
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Incidence of BPAR will be estimated with Kaplan-Meier analysis
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up to 12 months after liver transplantation
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Graft survival
大体时间：up to 9 years after liver transplantation
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incidence of graft loss will be estimated Kaplan-Meier analysis
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up to 9 years after liver transplantation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of patients with tacrolimus-associated adverse events
大体时间：up to 9 years after liver transplantation
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Common adverse events of tacrolimus such as nephrotoxicity, post-transplant diabetes mellitus, hypertension, infection, hyperlipidemia and malignancy.
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up to 9 years after liver transplantation
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Patient survival
大体时间：up to 9 years after liver transplantation
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incidence of death
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up to 9 years after liver transplantation
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合作者和调查者
调查人员
- 首席研究员：Rey-Heng Hu, Professor、National Taiwan University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.