NCT01018914已完成4 期
A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Incidence of biopsy confirmed acute rejection
研究概览
简要总结
To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.
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
- 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
- •Patient is a primary liver transplant recipient
- •Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
- •Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- •Patient must receive 1st dose of study drug within 24 hours of pre-transplantation
排除标准
- •Patient has previously received or is receiving an organ transplant other than a liver
- •Patient currently requires dialysis
- •Patient has received a liver transplant from a non-heart beating donor
- •Patient has received an ABO incompatible donor liver
- •Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- •Patient has fulminant hepatic failure, unless hemodynamically stable
- •Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
- •Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
- •Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
- •Patient is pregnant or lactating
研究组 & 干预措施
Prograf with Myfortic
Active Comparator
干预措施: Prograf (Drug)
Prograf with Myfortic
Active Comparator
干预措施: Myfortic (Drug)
Advagraf with Myfortic
Experimental
干预措施: Advagraf (Drug)
Advagraf with Myfortic
Experimental
干预措施: Myfortic (Drug)
结局指标
主要结局
Incidence of biopsy confirmed acute rejection
时间窗: during the 6 months post-transplant.
次要结局
- Patient and graft survival rates(during the 6 months post-transplant)
- Time to first biopsy confirmed acute rejection episode(during the 6 months post-transplant)
- Incidence of anti-lymphocyte antibody therapy for treatment of rejection(during the 6 months post-transplant.)
- Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs(throughout the study)
研究者
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