EUCTR2011-003069-14-IT进行中（未招募）1 期
A 24-month, multi-center, single arm, prospective study to evaluate renal function, efficacy, safety and tolerability of everolimus in combination with reduced exposure cyclosporine or tacrolimus in paediatric liver transplant recipients
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
- 75
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. A signed informed consent/assent must have been obtained from both parents or legal guardian(s) prior to patient participation in the study. 2. Paediatric liver transplant recipients aged greater than or equal to 1 month and younger than 18 years of age. 3. Paediatric liver transplant recipients at the earliest 1 month and latest 6 month after liver transplantation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •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
- •1. Patients who experienced more than two episodes of tBPAR or who received T-cell depleting induction agents or acute rejection therapy. 2. Patients with hepato-biliary malignancies. 3. Patients transplanted due to fulminant hepatitis/acute liver failure. 4. Presence of thrombosis of any major hepatic arteries, major/reconstructed hepatic veins, portal vein or inferior vena cava at any time prior to the start of everolimus treatment (graft vessel patency by Doppler ultrasound confirmed and documented). 5. Patients with serum creatinine value >2 times age-related ULN at baseline or who received renal replacement therapy within one week prior to the start of everolimus treatment. 6. Patients with a confirmed spot urine protein/creatinine ratio indicating a urinary protein excretion >500 mg/m2/24 hrs, at baseline. 7. Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an ABO incompatible transplant. 8. Patients who have severe hypercholesterolemia (>215 mg/dL; >5.5 mmol/L) or hypertriglyceridemia (>265 mg/dL; >3.0 mmol/L) at Baseline. 9. Patients with platelet count <35,000 mm3 and/or an absolute neutrophil count <1,000/mm3 or white blood cell count of <2,000/mm3 at Baseline. 10. Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drug. 11. Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients. 12. Patients with clinically significant systemic infection and/or in a critical care setting requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents. 13. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive ßHCG laboratory test (>9 mIU/mL) at Baseline. 14. Female patients of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they agree for abstinence from sexual activity
研究者
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