A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
Status: | Enrolling by invitation |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any - 75 |
Updated: | 4/21/2016 |
Start Date: | February 2015 |
End Date: | September 2016 |
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
The objective is data collection to determine background rates of adenovirus (AdV)
progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.
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.
adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection
and/or disease.
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
We found this trial at
22
sites
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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University of Utah Research is a major component in the life of the U benefiting...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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