EUCTR2008-006980-35-IT进行中（未招募）不适用
Efficacy and safety of anti-cytomegalovirus prophylaxis versus pre-emptive approaches with valganciclovir in heart transplant recipients treated with everolimus or mycophenolate. A randomized open-label study for prevention of cardiac allograft vasculopathy - PROTECT
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2009年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Age ≥ 18y - Heart or heart-kidney combined transplant - Positive CMV serology at the time of transplant - Glomerular filtration rate ≥ 20 ml/min/1.73m2 estimated with MDRD formula at the time of randomization. - Written informed consent
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Panel Reactive Antibody ≥50% - Less than 1000/mmc neutrophils at the time of randomization - Less than 30,000/mmc platelets at the time of randomization - Clinical significant infection in the 2 weeks prior to transplant - Glomerular filtration rate < 20 ml/min/1.73m2 estimated with MDRD formula at the time of randomization or hemodyalisis treatment - Intolerance towards valganciclovir, everolimus, mycophenolate or cyclosporine - Known contraindication to statin use - Negative CMV serology at the time of transplant - HIV positive testing - Severe comorbidities that, based on investigator?s judgment, contraindicate study drugs or procedures - Potentially childbearing women who refuse to use contraceptives - Participation to an interventional study in the 2 preceding weeks - Unwillingness or inability to follow study procedure and to sign written informed consent
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