跳至主要内容
临床试验/NCT01137084
NCT01137084已完成不适用

Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
patient and graft survival

研究概览

简要总结

The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment

排除标准

  • the recipient pass away within 3 month following up liver transplantation
  • Inability to provide written informed consent prior to study entry
  • acute rejection are treated only with steroids

研究组 & 干预措施

a steroid immunosuppression protocol

Active Comparator

干预措施: solu medrol (Drug)

a steroid-free immunosuppression protocol

Active Comparator

without steroid

干预措施: a steroid-free immunosuppression protocol (Drug)

结局指标

主要结局

patient and graft survival

时间窗: Over 12-month after liver transplantation

patient and graft survival include surviral rate and recurrence-free survival rate

次要结局

  • Postoperative complications(Over 12-month after liver transplantation)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other

研究点 (1)

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