NCT00189761已完成2 期
A Phase 2, Open-Label, Multi-Center Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in De Novo Bone Marrow Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor.
- •The patient had been fully informed.
排除标准
- •The patient had severe impaired hepatic function.
- •The patient had impaired renal function.
- •The patient had existing complication of severe cardiac dysfunction.
- •The patient had severe impaired pulmonary function.
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant PatientsLiver TransplantationNCT00282256Astellas Pharma Inc19
已完成
2 期
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing RegimenCompliance, PatientGraft FailureHeart Transplant RejectionNCT03373227Baylor Research Institute50
已完成
4 期
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation RecipientsKidney TransplantationLiver TransplantationNCT05152628Astellas Pharma China, Inc.55
已完成
4 期
Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.Kidney TransplantNCT04102943Chong Kun Dang Pharmaceutical128
已完成
4 期
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver TransplantationLiver TransplantationNCT01339468Astellas Pharma Inc100