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

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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

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.

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
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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201 Dowman Dr
Atlanta, Georgia 30303
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Bronx, New York 10467
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Chicago, Illinois 60614
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Cincinnati, Ohio 45229
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Memphis, Tennessee 38105
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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New Orleans, Louisiana 70118
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New York, New York 10065
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Omaha, Nebraska 68198
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Salt Lake City, Utah 84143
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Washinton, District of Columbia 20010
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