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Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Maribavir (100 mg twice daily) | Experimental |
| |
| Maribavir (400 mg twice daily) | Experimental |
| |
| Maribavir (400 mg once daily) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maribavir | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety as measured by the recording of treatment emergent adverse events | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CMV disease | 13 weeks | |
| Incidence of CMV infection | 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | United States | |||
| UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18285548 | Derived | Winston DJ, Young JA, Pullarkat V, Papanicolaou GA, Vij R, Vance E, Alangaden GJ, Chemaly RF, Petersen F, Chao N, Klein J, Sprague K, Villano SA, Boeckh M. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood. 2008 Jun 1;111(11):5403-10. doi: 10.1182/blood-2007-11-121558. Epub 2008 Feb 19. |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C400401 | maribavir |
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| Placebo |
| Drug |
|
| Los Angeles |
| California |
| United States |
| Loyola University | Maywood | Illinois | United States |
| Tufts-New England Medical Center | Boston | Massachusetts | United States |
| Wayne State Medical Center | Detroit | Michigan | United States |
| University of Minnesota | Minneapolis | Minnesota | United States |
| Washington University School of Medicine | St Louis | Missouri | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | United States |
| Duke Medical Center | Durham | North Carolina | United States |
| Baylor University Medical Center | Dallas | Texas | United States |
| MD Anderson Cancer Center | Houston | Texas | United States |
| University of Utah | Salt Lake City | Utah | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | United States |