EUCTR2009-012258-19-DE进行中（未招募）不适用
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus granules) in de novo Paediatric Allograft Recipients. - OPTION study
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
- 60
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
- •1. The subject is 12 years of age or younger.
- •2. The subject is the recipient of a solid organ (liver, kidney or heart) transplant. Multiorgan transplants are acceptable as long as one of the organs transplanted is liver, kidney or heart.
- •3. The subject’s parent(s) or their legal representative(s) has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1. The subject has previously received another organ transplant (including liver, kidney or heart re-transplantation).
- •2. Subject has a high immunological risk, defined as a Panel Reactive Antibody (PRA)
- •score >50% in the previous 6 months (only applicable for renal transplant recipients).
- •3. Cold ischemia time of the donor kidney greater than 30 hours (only applicable for renal transplant recipients).
- •4. Subject receives an AB0 incompatible donor organ.
- •5. Subject has significant renal impairment, defined as having serum creatinine =230
- •µmol/l (=2.6 mg/dl) pre-transplantation (not applicable for renal transplant recipients).
- •6. Subject has significant liver disease, defined as having elevated ALT and/or AST and/or Total Bilirubin levels 3 times the upper value of the normal range during the 28 days prior to transplantation (not applicable for liver transplant recipients).
- •7. Subject with pulmonary vascular resistance greater than 4 Wood units which is
- •unresponsive to treatment.
- •8. Subjects with malignancies or a history of malignancy within the last 5 years.
- •9. Subject has a significant, uncontrolled systemic infection and/or severe diarrhea,
- •vomiting, active upper gastrointestinal disorder that may affect the absorption of
- •tacrolimus or has an active peptic ulcer.
- •10. Subject requires systemic immunosuppressive medication for any indication other than transplantation.
- •11. Recipient or donor known to be HIV, HCV or HBV positive.
- •12. Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab or tacrolimus.
- •13. Subject is currently participating in another clinical trial and/or has been taking an
- •investigational drug in the 3 months prior to transplantation.
- •14. Subject is unlikely to comply with the visits scheduled in the protocol.
- •15. Subjects taking or requiring to be treated with medication or substances prohibited by this protocol.
研究者
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