NCT00909571已完成3 期
A Phase 3 Pilot Study to Describe the Pharmacokinetics of Tacrolimus in Patients Undergoing Primary Liver Donor Liver Transplantation Treated With Prograf Injection and Modified Release Tacrolimus Based Immunosuppressive Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Assessment of pharmacokinetic parameters
研究概览
简要总结
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
详细描述
To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving a primary partial liver graft from a living donor
- •Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study
排除标准
- •Patients receiving a multi-organ transplantation or having previously received an organ transplantation
- •Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
- •Patients allergic or intolerant to macrolide antibodies or Tacrolimus
研究组 & 干预措施
1. FK506E high dose group
Experimental
干预措施: FK506E (modified release tacrolimus) (Drug)
1. FK506E high dose group
Experimental
干预措施: Prograf (tacrolimus) (Drug)
2. FK506E low dose group
Experimental
干预措施: FK506E (modified release tacrolimus) (Drug)
2. FK506E low dose group
Experimental
干预措施: Prograf (tacrolimus) (Drug)
结局指标
主要结局
Assessment of pharmacokinetic parameters
时间窗: Day 6 and Day 14
次要结局
- Incidence of acute rejection(within 12 weeks)
- Time to acute rejection(within 12 weeks)
- Assessment of graft survival(within 12 weeks)
研究者
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