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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Cytomegalovirus Infections

Thank you

Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

CMV organ disease

Outcome Time Frame:

6 months post-transplant

Safety Issue:

No

Principal Investigator

Stephen A Villano, MD

Investigator Role:

Study Director

Investigator Affiliation:

ViroPharma

Authority:

United States: Food and Drug Administration

Study ID:

1263-300

NCT ID:

NCT00411645

Start Date:

December 2006

Completion Date:

May 2009

Related Keywords:

  • Cytomegalovirus Infections
  • prevention
  • prophylaxis
  • Cytomegalovirus
  • CMV
  • allogeneic stem cell transplant
  • SCT
  • Cytomegalovirus Infections

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
University of Rochester Medical CenterRochester, New York  14642
Hackensack University Medical CenterHackensack, New Jersey  07601
Latter Day Saints HospitalSalt Lake City, Utah  84143
Rocky Mountain Cancer CenterDenver, Colorado  80218
Brigham and Women's HospitalBoston, Massachusetts  02115
Baylor University Medical CenterDallas, Texas  75246
City of Hope Medical CenterDuarte, California  91010
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
University of OklahomaOklahoma City, Oklahoma  73190
University of MinnesotaMinneapolis, Minnesota  55455
Northwestern University Medical CenterChicago, Illinois  60611
Methodist HospitalHouston, Texas  77030
University of California, San FranciscoSan Francisco, California  94143
Medical College of VirginiaRichmond, Virginia  23298-0341
Henry Ford Health SystemDetroit, Michigan  48202
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Emory UniversityAtlanta, Georgia  30322
UCLA Medical CenterLos Angeles, California  90095-7059
Oregon Health and Sciences UniversityPortland, Oregon  
University of ChicagoChicago, Illinois  60637
Texas Transplant InstituteSan Antonio, Texas  78229
Shands HospitalGainesville, Florida  
Scripps Green HospitalLa Jolla, California  92037
Loyola UniversityMaywood, Illinois  60153
Vanderbilt Medical CenterNashville, Tennessee  37232-2765
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Mayo Clinic College of MedicineRochester, Minnesota  55905
University of Kentucky Chandler Medical CenterLexington, Kentucky  40536
Wayne State Medical CenterDetroit, Michigan  
Duke Medical CenterDurham, North Carolina  
Wake Forest Medical CenterWinston-Salem, North Carolina  27157
Greenbaum Cancer CenterBaltimore, Maryland  21201-1595
St Francis HospitalIndianapolis, Indiana  46107
University of Arkansas Myeloma InstituteLittle Rock, Arkansas  72205
UCSD Moores CenterLa Jolla, California  92093-0960
University Medical Center University of Louisville HospitalLouisville, Kentucky  40202
Massachusettes GeneralBoston, Massachusetts  02114
Mount Sinai HospitalNew York, New York  10029
New York Presbyterian Hospital,Weill Cornell Medical CenterNew York, New York  10021
University of North Carolina HospitalChapel Hill, North Carolina  27599
The Jewish HospitalCincinnati, Ohio  45236
Ireland Cancer Center Case Western Reserve UniversityCleveland, Ohio  44106
Jeanes Hospital - TemplePhiladelphia, Pennsylvania  19111
Thomas JeffersonPhiladelphia, Pennsylvania  19107
VA Puget Sound Health CenterSeattle, Washington  98108
West Virginia University HospitalMorgantown, West Virginia  26506-9162