Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
NCT ID: NCT00411645
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
681 participants
INTERVENTIONAL
2006-12-13
2009-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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A
maribavir
100 mg twice daily for up to 12 weeks
B
placebo
twice daily for up to 12 weeks
Interventions
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maribavir
100 mg twice daily for up to 12 weeks
placebo
twice daily for up to 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Recipient or donor CMV seropositive
* Have transplant engraftment
* Able to swallow tablets
Exclusion Criteria
* HIV infection
* Use of other anti-CMV therapy post-transplant
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Arkansas Myeloma Institute
Little Rock, Arkansas, United States
City of Hope Medical Center
Duarte, California, United States
Scripps Green Hospital
La Jolla, California, United States
UCSD Moores Center
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Shands Hospital
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
St Francis Hospital
Beech Grove, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
University Medical Center University of Louisville Hospital
Louisville, Kentucky, United States
Greenbaum Cancer Center
Baltimore, Maryland, United States
Massachusettes General
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State Medical Center
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital,Weill Cornell Medical Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Duke Medical Center
Durham, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
The Jewish Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center Case Western Reserve University
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson
Philadelphia, Pennsylvania, United States
Jeanes Hospital - Temple
Philadelphia, Pennsylvania, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Medical College of Virginia
Richmond, Virginia, United States
VA Puget Sound Health Center
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
ZNA Stuivenberg
Antwerp, , Belgium
AZ Sint Jan, Department of Hematology
Bruges, , Belgium
Cliniques Universitaires St,Luc Dept Hematology
Brussels, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
CHU Sart -Tilman Department of Medicine, Hematology
Liège, , Belgium
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
McMaster University Medical Center
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa General Campus
Ottawa, Ontario, Canada
Hopital l'Enfant Jesus
Québec, Quebec, Canada
Hopital Henri Mondor
Créteil, , France
Edouard Herriot Hopital
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Hopital Hotel Dieu
Nantes, , France
Hopital St. Louis
Paris, , France
Hopital Haut-Leveque
Pessac, , France
Universitaetsklinikum Koeln, Clinic I for internal Medicine
Cologne, , Germany
Univ. Clinic Dresden
Dresden, , Germany
University Clinic of Dresden
Dresden, , Germany
University of Essen
Essen, , Germany
University of Freiburg
Freiburg im Breisgau, , Germany
University of Hamburg-Eppendorf
Hamburg, , Germany
Hannover, Medizinische Hochschule
Hanover, , Germany
University of Heidelberg
Heidelberg, , Germany
Johannes-Gutenberg University
Mainz, , Germany
University Clinic of Ulm
Ulm, , Germany
Careggi University Hospital
Florence, , Italy
University of San Martino Hospital
Genova, , Italy
San Raffaele del Monte Tabor
Milan, , Italy
Pescara Hospital
Pescara, , Italy
Bianchi-Melacrino-Morelli Hospital
Reggio Calabria, , Italy
Barcelona Hospital
Barcelona, , Spain
Duran i Reynals Hospital
Barcelona, , Spain
University of Salamanca
Salamanca, , Spain
Karolinska University Hospital
Huddinge, Stockholm County, Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Karolinska University Hospital,Huddinge
Stockholm, , Sweden
Akademiska Sjukhuset, Dept Hematology
Uppsala, , Sweden
University College Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Countries
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References
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Marty FM, Ljungman P, Papanicolaou GA, Winston DJ, Chemaly RF, Strasfeld L, Young JA, Rodriguez T, Maertens J, Schmitt M, Einsele H, Ferrant A, Lipton JH, Villano SA, Chen H, Boeckh M; Maribavir 1263-300 Clinical Study Group. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2011 Apr;11(4):284-92. doi: 10.1016/S1473-3099(11)70024-X. Epub 2011 Mar 21.
Other Identifiers
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2006-005692-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP620-300
Identifier Type: OTHER
Identifier Source: secondary_id
1263-300
Identifier Type: -
Identifier Source: org_study_id
NCT00430339
Identifier Type: -
Identifier Source: nct_alias
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