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

Stopped early

Conditions studied: Adenovirus

In brief

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

Key facts

Study ID

NCT02420080

Run by

Jazz Pharmaceuticals

People needed

100

Starts

2015-02-01

Expected to finish

2016-09-01

Last updated by the study team

2017-01-09

Who can join

Age: 0 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior use of BCV

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Childrens National Health System — Washinton, District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Children's Hospital New Orleans — New Orleans, Louisiana, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Memorial Sloan Kettering — New York, New York, United States
• The Children's Hospital at Montefiore — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hosital — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• St. Judes Children's Research Hospital — Memphis, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States
• Utah Cancer Specialist LDS Hospital — Salt Lake City, Utah, United States
• University of Washington_Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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