Study Stopped
Study was terminated early due to results from previous CMX study
A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
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
1 other identifier
observational
100
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2015
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJanuary 9, 2017
January 1, 2017
1.3 years
April 9, 2015
January 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cohort A (Time to progression of AdV disease through Week 36)
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.
36 weeks
Secondary Outcomes (1)
Cohort B (Time to all-cause mortality through Week 36)
36 weeks
Study Arms (2)
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
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
Interventions
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.
Eligibility Criteria
allogeneic hematopoietic cell transplant (HCT) recipients who were at risk of progression to disseminated AdV disease. Allogeneic hematopoietic cell transplant recipients with disseminated AdV disease
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Childrens National Health System
Washinton, District of Columbia, 20010, United States
Emory University
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University
St Louis, Missouri, 63130, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Memorial Sloan Kettering
New York, New York, 10021, United States
The Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Cincinnati Children's Hosital
Cincinnati, Ohio, 45229, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
St. Judes Children's Research Hospital
Memphis, Tennessee, 38105, United States
University of Utah
Salt Lake City, Utah, 84113, United States
Utah Cancer Specialist LDS Hospital
Salt Lake City, Utah, 84143, United States
University of Washington_Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 17, 2015
Study Start
February 1, 2015
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
January 9, 2017
Record last verified: 2017-01