A Multicenter Non-Interventional Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Chimerix
- 入组人数
- 100
- 试验地点
- 22
- 主要终点
- Cohort A (Time to progression of AdV disease through Week 36)
研究概览
简要总结
The objective is data collection to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.
详细描述
The objective of this retrospective data collection is to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Matched-control cases must be recruited from sites participating in the CMX001-304 study and meet all of the following criteria, as applicable, to be eligible for data abstraction in this non-interventional retrospective study:
- •Age at time of transplant: ≥ 2 months
- •Eligible matched-control subjects must meet the disease conditions of one or both of the two cohorts listed below on or after Jan 1, 2004 and prior to Mar 12,
- •If subjects had more than one study-qualifying episode of these disease conditions on or after Jan 1, 2004 and prior to Mar 12, 2014, only the most recent qualifying episode should be included:
- •Cohort A: allogeneic hematopoietic cell transplantation (HCT) recipients who were at risk of progression to disseminated AdV disease, defined as documented evidence of 1) asymptomatic AdV viremia ≥ 1,000 copies/mL, increasing, OR 2) localized AdV infection
- •Cohort B: allogeneic HCT recipients with disseminated AdV disease
排除标准
- •Prior use of BCV
研究组 & 干预措施
Cohort A
The primary endpoint for subjects in Cohort A is time to progression of AdV disease through Week 24 post initial AdV diagnosis, with progression of AdV disease defined as time to the following outcomes:
Clinical progression to probable or definitive disseminated AdV disease Death
干预措施: Brincidofovir (Drug)
Cohort B
The primary endpoint for subjects in Cohort B is time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease
干预措施: Brincidofovir (Drug)
结局指标
主要结局
Cohort A (Time to progression of AdV disease through Week 36)
时间窗: 36 weeks
Time to progression of AdV disease through Week 36 post initial AdV diagnosis, with progression of AdV disease defined as time to the occurrence of either clinical progression to probable or definitive disseminated AdV disease or Death.
次要结局
- Cohort B (Time to all-cause mortality through Week 36)(36 weeks)