Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.
3 other identifiers
interventional
681
9 countries
97
Brief Summary
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
97 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
First Submitted
Initial submission to the registry
December 12, 2006
CompletedStudy Start
First participant enrolled
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2009
CompletedResults Posted
Study results publicly available
June 3, 2015
CompletedJune 11, 2021
June 1, 2021
1.9 years
December 12, 2006
May 15, 2015
June 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell \[WBC\] count \<3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was \>4000/mm3) \>/=24 hours apart, atypical lymphocytosis \>/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
6 months post-transplant
Secondary Outcomes (10)
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant
6 months post-transplant
Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation
6 months post-transplant
Number of Participants With Investigator-determined CMV Disease
Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
100 days post-transplant
Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation
12 months post-transplant
- +5 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Allogeneic stem cell transplant recipient
- Recipient or donor CMV seropositive
- Have transplant engraftment
- Able to swallow tablets
You may not qualify if:
- CMV organ disease
- HIV infection
- Use of other anti-CMV therapy post-transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (97)
University of Arkansas Myeloma Institute
Little Rock, Arkansas, 72205, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
UCSD Moores Center
La Jolla, California, 92093-0960, United States
UCLA Medical Center
Los Angeles, California, 90095-1678, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Shands Hospital
Gainesville, Florida, 32610, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University
Maywood, Illinois, 60153, United States
St Francis Hospital
Beech Grove, Indiana, 46107, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
University Medical Center University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Greenbaum Cancer Center
Baltimore, Maryland, 21201-1595, United States
Massachusettes General
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109-0914, United States
Wayne State Medical Center
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian Hospital,Weill Cornell Medical Center
New York, New York, 10021, United States
Mount Sinai Hospital
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599, United States
Duke Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157, United States
The Jewish Hospital
Cincinnati, Ohio, 45236, United States
Ireland Cancer Center Case Western Reserve University
Cleveland, Ohio, 44106, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Sciences University
Portland, Oregon, 97239-3098, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson
Philadelphia, Pennsylvania, 19107, United States
Jeanes Hospital - Temple
Philadelphia, Pennsylvania, 19111, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Methodist Hospital
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Latter Day Saints Hospital
Salt Lake City, Utah, 84103, United States
Medical College of Virginia
Richmond, Virginia, 23298, United States
VA Puget Sound Health Center
Seattle, Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506-9162, United States
ZNA Stuivenberg
Antwerp, 2060, Belgium
AZ Sint Jan, Department of Hematology
Bruges, 8000, Belgium
Cliniques Universitaires St,Luc Dept Hematology
Brussels, 1200, Belgium
UZ Gasthuisberg
Leuven, 3000, Belgium
CHU Sart -Tilman Department of Medicine, Hematology
Liège, 4000, Belgium
QEII Health Sciences Center
Halifax, Nova Scotia, B3H2Y9, Canada
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Ottawa General Campus
Ottawa, Ontario, K1H 8L6, Canada
Hopital l'Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Hopital Henri Mondor
Créteil, 94010, France
Edouard Herriot Hopital
Lyon, 69437, France
Institut Paoli Calmettes
Marseille, 13273, France
Hopital Hotel Dieu
Nantes, 44093, France
Hopital St. Louis
Paris, 75475, France
Hopital Haut-Leveque
Pessac, 33600, France
Universitaetsklinikum Koeln, Clinic I for internal Medicine
Cologne, 50937, Germany
Univ. Clinic Dresden
Dresden, 01307, Germany
University Clinic of Dresden
Dresden, 01307, Germany
University of Essen
Essen, 45122, Germany
University of Freiburg
Freiburg im Breisgau, 79106, Germany
University of Hamburg-Eppendorf
Hamburg, 20246, Germany
Hannover, Medizinische Hochschule
Hanover, 30625, Germany
University of Heidelberg
Heidelberg, 69120, Germany
Johannes-Gutenberg University
Mainz, 55131, Germany
University Clinic of Ulm
Ulm, 89081, Germany
Careggi University Hospital
Florence, 50134, Italy
University of San Martino Hospital
Genova, 16132, Italy
San Raffaele del Monte Tabor
Milan, 20132, Italy
Pescara Hospital
Pescara, 65123, Italy
Bianchi-Melacrino-Morelli Hospital
Reggio Calabria, 89100, Italy
Barcelona Hospital
Barcelona, 08036, Spain
Duran i Reynals Hospital
Barcelona, 08907, Spain
University of Salamanca
Salamanca, E-37007, Spain
Karolinska University Hospital
Huddinge, Stockholm County, 14186, Sweden
Sahlgrenska University Hospital
Gothenburg, S-413 45, Sweden
Karolinska University Hospital,Huddinge
Stockholm, 141 86, Sweden
Akademiska Sjukhuset, Dept Hematology
Uppsala, 751 85, Sweden
University College Hospital
London, NW1 2BU, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Hammersmith Hospital
London, W12 OHS, United Kingdom
Related Publications (1)
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.
PMID: 21414843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2006
First Posted
December 14, 2006
Study Start
December 13, 2006
Primary Completion
November 10, 2008
Study Completion
May 23, 2009
Last Updated
June 11, 2021
Results First Posted
June 3, 2015
Record last verified: 2021-06