跳至主要内容
临床试验/NCT02062294
NCT02062294已完成不适用

Retrospective Review of Valganciclovir Efficacy in Preventing CMV Disease in D+/R- Liver Transplant Recipients - A Non-Interventional Program

Hoffmann-La Roche3 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2010年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
3
主要终点
Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis

研究概览

简要总结

This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from eligible patients will be collected for the 6 months following transplantation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Liver transplant recipients, >/= 16 years of age
  • Transplantation between January 2004 and June 2009
  • CMV seronegative recipient (R-) who received a liver transplant from a seropositive donor (D+)
  • Valganciclovir therapy for at least 70 days beginning within 10 days post transplantation
  • Assessment of CMV disease status within the first 6 months post transplantation

排除标准

  • 未提供

结局指标

主要结局

Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis

时间窗: 6 months

Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.

次要结局

  • Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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