EUCTR2011-003069-14-SE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 - 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
- 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
- •Since 18 Dec 2014 and based on the DMC recommendation, the study has been closed for further enrolment. In addition, as of 6 Feb 2015, patients younger than 7 years of age must be discontinued from the study treatment and converted to standard of care immunosuppression (immunosuppressive treatment or regimen used at the site).
- •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 (>350 mg/dL; >9.1 mmol/L ) or hypertriglyceridemia (>500 mg/dL; >5.6 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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