A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
- Registration Number
- NCT02420080
- Lead Sponsor
- Chimerix
- Brief Summary
The objective is data collection to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- 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
- Prior use of BCV
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A Brincidofovir 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 Cohort B Brincidofovir The primary endpoint for subjects in Cohort B is time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease
- Primary Outcome Measures
Name Time Method Cohort A (Time to progression of AdV disease through Week 36) 36 weeks Time to progression of AdV disease through Week 36 post initial AdV diagnosis, with progression of AdV disease defined as time to the occurrence of either clinical progression to probable or definitive disseminated AdV disease or Death.
- Secondary Outcome Measures
Name Time Method Cohort B (Time to all-cause mortality through Week 36) 36 weeks Time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease
Trial Locations
- Locations (22)
University of Chicago
🇺🇸Chicago, Illinois, United States
Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Brigham and Womens Hospital
🇺🇸Boston, Massachusetts, United States
University of Washington_Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Childrens National Health System
🇺🇸Washinton, District of Columbia, United States
Children's Hospital New Orleans
🇺🇸New Orleans, Louisiana, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
The Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Memorial Sloan Kettering
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hosital
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
St. Judes Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Utah Cancer Specialist LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States