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.
18 Years
N/A
Both
Cytomegalovirus Infections
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 Michigan | Ann Arbor, Michigan 48109-0624 |
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| City of Hope Medical Center | Duarte, California 91010 |
| Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania 15224 |
| University of Oklahoma | Oklahoma City, Oklahoma 73190 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| Northwestern University Medical Center | Chicago, Illinois 60611 |
| Methodist Hospital | Houston, Texas 77030 |
| University of California, San Francisco | San Francisco, California 94143 |
| Medical College of Virginia | Richmond, Virginia 23298-0341 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| Emory University | Atlanta, Georgia 30322 |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Oregon Health and Sciences University | Portland, Oregon |
| University of Chicago | Chicago, Illinois 60637 |
| Texas Transplant Institute | San Antonio, Texas 78229 |
| Shands Hospital | Gainesville, Florida |
| Scripps Green Hospital | La Jolla, California 92037 |
| Loyola University | Maywood, Illinois 60153 |
| Vanderbilt Medical Center | Nashville, Tennessee 37232-2765 |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Mayo Clinic College of Medicine | Rochester, Minnesota 55905 |
| University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536 |
| Wayne State Medical Center | Detroit, Michigan |
| Duke Medical Center | Durham, North Carolina |
| Wake Forest Medical Center | Winston-Salem, North Carolina 27157 |
| Greenbaum Cancer Center | Baltimore, Maryland 21201-1595 |
| St Francis Hospital | Indianapolis, Indiana 46107 |
| University of Arkansas Myeloma Institute | Little Rock, Arkansas 72205 |
| UCSD Moores Center | La Jolla, California 92093-0960 |
| University Medical Center University of Louisville Hospital | Louisville, Kentucky 40202 |
| Massachusettes General | Boston, Massachusetts 02114 |
| Mount Sinai Hospital | New York, New York 10029 |
| New York Presbyterian Hospital,Weill Cornell Medical Center | New York, New York 10021 |
| University of North Carolina Hospital | Chapel Hill, North Carolina 27599 |
| The Jewish Hospital | Cincinnati, Ohio 45236 |
| Ireland Cancer Center Case Western Reserve University | Cleveland, Ohio 44106 |
| Jeanes Hospital - Temple | Philadelphia, Pennsylvania 19111 |
| Thomas Jefferson | Philadelphia, Pennsylvania 19107 |
| VA Puget Sound Health Center | Seattle, Washington 98108 |
| West Virginia University Hospital | Morgantown, West Virginia 26506-9162 |
