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Study was terminated early due to results from previous CMX study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brincidofovir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort B (Time to all-cause mortality through Week 36) | Time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease | 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Childrens National Health System |
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| 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 |
| ID | Term |
|---|---|
| D000257 | Adenoviridae Infections |
| ID | Term |
|---|---|
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C525733 | brincidofovir |
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