IRCT20150303021315N25招募中4 期
Open-label, randomized study to evaluate efficacy and safety of Suprotac® in comparison with Prograf® in liver transplant patients in Iran
anoalvand Company0 个研究点目标入组 196 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 70 years（—）
- 性别
- All
入选标准
- •Patient aged between 18 to 70 years
- •Patient who has passed two months from transplantation surgery
- •Patient who has received a stable dose of tacrolimus (prograf®) in the last 14 days before enrolment
- •Ability to comprehend and willing to sign the informed consent form for this study
排除标准
- •Use of other investigational drugs at the time or within 30 days of enrolment, or within five half-lives of those drugs, whichever is longer (except for dialysis-related drugs which are not expected to interact with the study regimens)
- •Patients with contraindication for tacrolimus or any other ingredients of the formulation
- •Patients who underwent liver transplant rejection in the first two months after liver transplantation
- •Patients with Glomerular Filtration Rate greater than 30 at the time of enrolment to the study (two months after liver transplantation)
研究者
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