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

N/ATerminatedNCT02420080

Jazz Pharmaceuticals100 enrolled

Overview

The objective is data collection to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Adenovirus

Interventions

BrincidofovirDRUG

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (22)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 36 weeks

Secondary Outcomes

Cohort B (Time to all-cause mortality through Week 36)

Time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease

Time frame: 36 weeks

Data from ClinicalTrials.gov

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