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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Chimerix
- Enrollment
- 100
- Locations
- 22
- Primary Endpoint
- Cohort A (Time to progression of AdV disease through Week 36)
Study Overview
Brief Summary
The objective is data collection to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 2 Months to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Prior use of BCV
Arms & Interventions
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
Intervention: 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
Intervention: Brincidofovir (Drug)
Outcomes
Primary Outcomes
Cohort A (Time to progression of AdV disease through Week 36)
Time Frame: 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.
Secondary Outcomes
- Cohort B (Time to all-cause mortality through Week 36)(36 weeks)