临床试验/NCT03603548

NCT03603548Unknown不适用

Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial

Medical University of Warsaw1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2018年7月9日最近更新: 2018年7月27日

适应症

干预措施

试验速览

阶段: 不适用
发起方
入组人数: 200
试验地点: 1
主要终点: acute rejection

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation

排除标准

•liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease

研究组 & 干预措施

Advagraf

Active Comparator

干预措施: Advagraf (Drug)

Envarsus

Experimental

干预措施: Envarsus (Drug)

结局指标

主要结局

acute rejection

时间窗: 12 months

chronic rejection

时间窗: 5 years

tremor

时间窗: 12 months

de novo diabetes

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方

Medical University of Warsaw

申办方类型

Other

责任方

Sponsor

研究点 (1)

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