A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
NCT ID: NCT02420080
Last Updated: 2017-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
100 participants
OBSERVATIONAL
2015-02-28
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Cohort A
The primary endpoint for subjects in Cohort A is time to progression of AdV disease through Week 24 post initial AdV diagnosis, with progression of AdV disease defined as time to the following outcomes:
Clinical progression to probable or definitive disseminated AdV disease Death
Brincidofovir
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.
Cohort B
The primary endpoint for subjects in Cohort B is time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease
Brincidofovir
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.
Interventions
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Brincidofovir
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2 Months
75 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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CMX001-305
Identifier Type: -
Identifier Source: org_study_id
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