Maribavir for Prevention of CMV After Stem Cell Transplants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00223925
First received: September 13, 2005
Last updated: March 25, 2015
Last verified: March 2014
  Purpose

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 Intervention Phase
Cytomegalovirus Infection
Drug: Maribavir
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Clinical safety as measured by the recording of treatment emergent adverse events [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of CMV disease [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Incidence of CMV infection [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: October 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Shire

Additional 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
Study First Received: September 13, 2005
Last Updated: March 25, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Stem cell transplantation
Allogeneic transplantation

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

ClinicalTrials.gov processed this record on September 03, 2015