EUCTR2014-002150-39-BE进行中（未招募）1 期
A multi-center, randomized, double-blind, placebo controlled, study to evaluate the efficacy and safety of CSJ148 compared to placebo to prevent human cytomegalovirus (HCMV) replication in stem cell transplant patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
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
- •Inclusion Criteria:
- •- Male and female patients at least 18 years of age scheduled to undergo allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation and begin conditioning chemotherapy within 24-48 hours of planned dosing day.
- •- Subject seropositive for HCMV before transplantation; donor can be seropositive or seronegative for HCMV (donor positive/recipient positive or donor negative/recipient positive).
- •other protocol-defined inclusion criteria may apply”
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Exclusion Criteria:
- •- Have had HCMV-related organ disease within 6 months prior to enrollment.
- •- Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase chain reaction (PCR) assays prior to enrollment
- •- Received any of the following within 30 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3 gm/day oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin (>500 mg/kg), or any other medication with anti-HCMV activity.
- •- Require mechanical ventilation within 7 days prior to enrollment.
- •- Received any vasopressors or other agents for hemodynamic support within 7 days prior to enrollment.
- •- Impaired renal function requiring dialysis.
- •other protocol-defined exclusion criteria may apply”
研究者
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