NCT00459719已完成3 期
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Event rate of patients with acute rejections
研究概览
简要总结
The patients about to undergo liver transplantation will be randomized to one of the following two group:
Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Written informed consent with the date of the patient must be obtained.
- •Patient between 18-70 years of age receiving the primary liver.
- •Female patients must have a negative pregnancy test prior to the enrolment.
- •Female patients of child bearing potential must agree to practice effective birth control during the study
排除标准
- •Liver re-transplantation patients or received an organ transplantation other than a liver.
- •Living-related liver transplantation patient.
- •Patient has received an AB0 incompatible donor liver.
- •Patient who needs antibody induction therapy.
- •Patient with sever infection requiring treatment.
- •Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.
研究组 & 干预措施
1
Experimental
In combination with steroids
干预措施: Tacrolimus modified-release (Drug)
2
Active Comparator
In combination with steroids
干预措施: Prograf (Drug)
结局指标
主要结局
Event rate of patients with acute rejections
时间窗: 12 Weeks
次要结局
- Incidence of and time to acute rejections(12 Weeks)
- Overall frequency of acute rejections(12 Weeks)
- Rate of patient and graft survival following transplantation.(12 weeks)
研究者
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