EUCTR2009-011008-43-IT进行中（未招募）不适用
Early vs.delayed EVERolimus in de novo HEART transplant recipients: optimozation of the safety/efficacy profile (EVERHEART Study) - EVERHEART
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria: To be checked at screening: - male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation; - patients who have given written informed consent to participate in the study. To be checked at randomization: - GFR (by MDRD) ≥ 40 mL/min/1.73m2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •To be checked at screening: - patients who are recipients of multiple solid organ transplants; - known hypersensitivity to rapamycin derivatives; - Known intolerance to cyclosporine or statins - patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive; - presence of Donor/Recipient serological mismatch for Hepatitis B or C; - recipients of organ from donors positive for Hepatitis B-surface antigen; - Panel Reactive Antibodies (cytotoxicity method) > 30%; - patients who are taking other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; - females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. To be checked at randomization - platelet count <40,000 /mm3 ; - WBC ≤ 4.000/ mm3 ; - clinically significant systemic infection; - donor older than 60 years and/or with known donor heart disease at the time of transplant; - cold ischemia time > 6 hours; - patients unable to take oral medication; - patients who need treatment with drugs that are strong inducers or inhibitors of cytochrome P450 3A4
研究者
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