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Maribavir for Prevention of CMV After Stem Cell Transplants

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ClinicalTrials.gov Identifier: NCT00223925
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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 anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Drug: Maribavir Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants
Study Start Date : October 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: Maribavir (100 mg twice daily) Drug: Maribavir
Experimental: Maribavir (400 mg twice daily) Drug: Maribavir
Experimental: Maribavir (400 mg once daily) Drug: Maribavir



Primary Outcome Measures :
  1. Clinical safety as measured by the recording of treatment emergent adverse events [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Incidence of CMV disease [ Time Frame: 13 weeks ]
  2. Incidence of CMV infection [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allogeneic stem cell transplant recipient
  • Recipient CMV seropositive
  • Have transplant engraftment
  • Able to swallow tablets

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223925


Locations
United States, California
City of Hope Medical Center
Duarte, California, United States
UCLA Medical Center
Los Angeles, California, United States
United States, Illinois
Loyola University
Maywood, Illinois, United States
United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States
United States, Michigan
Wayne State Medical Center
Detroit, Michigan, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Sponsors and Collaborators
Shire

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00223925     History of Changes
Other Study ID Numbers: 1263-200
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2014

Keywords provided by Shire:
Stem cell transplantation
Allogeneic transplantation

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases