EUCTR2011-000078-80-BE进行中（未招募）1 期
A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study toCompare the Pharmacokinetics of Tacrolimus in De Novo Pediatric AllograftRecipients Treated with an Advagraf or Prograf Based ImmunosuppressiveRegimen, Including a Long-Term Follow-Up - Not applicable
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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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