A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Adenovirus

Intervention / Treatment
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* Drug: Brincidofovir


Participation Criteria
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Eligibility Criteria
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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, 2014. 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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>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 | Drug: Brincidofovir<br>* Rates of adenovirus progression and mortality in subjects with adenovirus infection and/or disease. Sites participating in the CMX001-304 study will be asked to participate in the CMX001-305 study retrospective data collection study.<br>* Other names: CMX001;|
| Cohort B<br>The primary endpoint for subjects in Cohort B is time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease | Drug: Brincidofovir<br>* Rates of adenovirus progression and mortality in subjects with adenovirus infection and/or disease. Sites participating in the CMX001-304 study will be asked to participate in the CMX001-305 study retrospective data collection study.<br>* Other names: CMX001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort A (Time to progression of AdV disease through Week 36) | 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. | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort B (Time to all-cause mortality through Week 36) | Time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease | 36 weeks |