EUCTR2011-000078-80-GB进行中（未招募）不适用
A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study to Compare the Pharmacokinetics of Tacrolimus in De Novo Pediatric Allograft Recipients Treated with an Advagraf or Prograf Based Immunosuppressive Regimen, Including a Long-Term Follow-Up - PMR-EC-1207
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- The subject is aged < 16 years of age, undergoing primary liver, kidney or
- •heart allograft transplantation.
- •- The subject must be able to swallow intact Prograf® or Advagraf® capsules.
- •- Subjects, treated since transplantation with Basiliximab or ATG/ Mycophenolate
- •Mofetil (MMF)/steroids, whose gastric motility has resumed and whose renal function is adequate on Day 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 64
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Subject is receiving a multi-organ transplant or has previously received an
- •organ transplant (including re-transplantation).
- •- Subject with pulmonary vascular resistance =4 Wood units despite medication.
- •- Subject with significant renal impairment, defined as having serum creatinine =230 µmol/l (=2.6 mg/dl) pre-transplantation. (Not applicable for renal transplanted subjects)
- •- Subject with significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels of =3 times the upper value of the normal range of the investigational site during the past 28 days. (Not applicable for liver transplanted subjects)
- •- Subject with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully. (Not applicable for
- •transplanted subjects with a primary organ diagnosis of cancer)
- •- Subject requiring systemic immunosuppressive medication for any other
- •indication than transplantation.
研究者
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