EUCTR2019-002233-11-ES进行中（未招募）1 期
The proposed study is a phase IV, randomized, controlled, multicenter and open clinical trial, with two parallel groups, to evaluate the effectiveness of a preventive strategy against CMV infection in heart transplant patients with positive serology against CMV based on T cells responses to IE-1 and pp65 CMV antigens, determined by ELISPOT IFN-? assay - ELISPOT-TC
Dr. José González Costello.Unidad de Insuficiencia cardíaca avanzada y Trasplante cardíaco. Hospital Univ. Bellvitge0 个研究点目标入组 188 人开始时间: 2019年12月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 188
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
入选标准
- •1) Adult patients (18 years or more), both sexes, heart transplant patients.
- •2) Patients with positive IgG against CMV (seropositive).
- •3) Informed consent given by the subject or his legal representative.
- •4) Availability of obtaining recipient and donor serologies.
- •5) Women of childbearing age who use effective contraceptive methods during and for at least 30 days after treatment. Men who use barrier contraceptive methods during and for at least 90 days after treatment, unless there is certainty that the female partner can’t get pregnant.
- •6) Availability of obtaining biological samples of peripheral blood post-transplant to be able to perform the ELISPOT IFN-? assay.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 88
排除标准
- •1) Pregnancy and / or lactation.
- •2) Patients with biological samples in poor condition at visit 2 (at 10 days post-HT) that prevent the determination of immunological tests.
- •3) Patients receiving thymoglobulin as induction therapy.
- •4) Patients with contraindication for the use of ganciclovir or valganciclovir.
研究者
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