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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5801 South Ellis Avenue
Chicago, Illinois 60637
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75 Francis street
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2401 Gillham Rd
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4650 Sunset Blvd
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Minneapolis, Minnesota 55455
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South 34th Street
Philadelphia, Pennsylvania 19104
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201 Presidents Circle
Salt Lake City, Utah 84108
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1 Brookings Drive
St. Louis, Missouri 63110
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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
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919-684-8111
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Memphis, Tennessee 38105
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8701 W Watertown Plank Rd
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3414 Fifth Avenue
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Washinton, District of Columbia 20010
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