The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- CMV viral load
研究概览
简要总结
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection
- •receiving no more than 48 hrs of therapy prior to study enrollment
排除标准
- •serum creatinine <2.2 at the time of enrollment
- •no prior use of CMV IgG
研究组 & 干预措施
1
Cytogam in addition to standard of care (IV ganciclovir therapy)
干预措施: CMV Immune globulin (Drug)
结局指标
主要结局
CMV viral load
时间窗: 12 months
次要结局
未报告次要终点