Clinical trial NCT00411645: Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Infections
Keywords: prevention
prophylaxis
Cytomegalovirus
CMV
allogeneic stem cell transplant
SCT
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 681
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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 efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.

Eligibility criteria: Inclusion Criteria:

* Allogeneic stem cell transplant recipient
* Recipient or donor CMV seropositive
* Have transplant engraftment
* Able to swallow tablets

Exclusion Criteria:

* CMV organ disease
* HIV infection
* Use of other anti-CMV therapy post-transplant

Primary outcomes:
measure: Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
timeFrame: 6 months post-transplant
Secondary outcomes:
measure: Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant
timeFrame: 6 months post-transplant
measure: Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation
timeFrame: 6 months post-transplant
measure: Number of Participants With Investigator-determined CMV Disease
timeFrame: Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)
measure: Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
timeFrame: 100 days post-transplant
measure: Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation
timeFrame: 12 months post-transplant
measure: Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)
timeFrame: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)
measure: Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)
timeFrame: Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)
measure: Number of Participants Who Died Within 12 Months Post-Transplantation
timeFrame: Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant)
measure: Plasma Concentration of Maribavir During Treatment
timeFrame: 12 hours post-dose after 1 and 4 weeks of treatment
measure: Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment
timeFrame: 12 hours post-dose after 1 and 4 weeks of treatment
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas Myeloma Institute
state: Arkansas
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: La Jolla
country: United States
facility: UCSD Moores Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Gainesville
country: United States
facility: Shands Hospital
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Beech Grove
country: United States
facility: St Francis Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University Medical Center University of Louisville Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Greenbaum Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusettes General
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic College of Medicine
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital,Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Jewish Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center Case Western Reserve University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jeanes Hospital - Temple
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Institute
state: Texas
city: Salt Lake City
country: United States
facility: Latter Day Saints Hospital
state: Utah
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Center
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Antwerp
country: Belgium
facility: ZNA Stuivenberg
city: Brugge
country: Belgium
facility: AZ Sint Jan, Department of Hematology
city: Brussels
country: Belgium
facility: Cliniques Universitaires St,Luc Dept Hematology
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liege
country: Belgium
facility: CHU Sart -Tilman Department of Medicine, Hematology
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa,
country: Canada
facility: Ottawa General Campus
state: Ontario
city: Quebec
country: Canada
facility: Hopital l'Enfant Jesus
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Lyon, Cedex 03
country: France
facility: Edouard Herriot Hopital
city: Marseille Cedex 9
country: France
facility: Institut Paoli Calmettes
city: Nantes, Cedex 1
country: France
facility: Hopital Hotel Dieu
city: Paris Cedex 10
country: France
facility: Hopital St. Louis
city: Pessac
country: France
facility: Hopital Haut-Leveque
city: Dresden
country: Germany
facility: Univ. Clinic Dresden
city: Dresden
country: Germany
facility: University Clinic of Dresden
city: Essen
country: Germany
facility: University of Essen
city: Freiburg
country: Germany
facility: University of Freiburg
city: Hamburg
country: Germany
facility: University of Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Hannover, Medizinische Hochschule
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln, Clinic I for internal Medicine
city: Mainz
country: Germany
facility: Johannes-Gutenberg University
city: Ulm
country: Germany
facility: University Clinic of Ulm
city: Firenze
country: Italy
facility: Careggi University Hospital
city: Genova
country: Italy
facility: University of San Martino Hospital
city: Milano
country: Italy
facility: San Raffaele del Monte Tabor
city: Pescara
country: Italy
facility: Pescara Hospital
city: Reggio Calabria
country: Italy
facility: Bianchi-Melacrino-Morelli Hospital
city: Barcelona
country: Spain
facility: Barcelona Hospital
city: Barcelona
country: Spain
facility: Duran i Reynals Hospital
city: Salamanca
country: Spain
facility: University of Salamanca
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
state: Stockholm
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital,Huddinge
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset, Dept Hematology
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.