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NCT00223925 Clinical Trial

Maribavir for Prevention of CMV After Stem Cell Transplants

Cytomegalovirus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00223925
Other study ID # 1263-200
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 28, 2004
Est. completion date April 5, 2006

Study information
Verified date May 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 111
Est. completion date April 5, 2006
Est. primary completion date April 5, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Maribavir

• Placebo

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

Sponsors (1)
Lead Sponsor Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical safety as measured by the recording of treatment emergent adverse events 13 weeks
Secondary Incidence of CMV disease 13 weeks
Secondary Incidence of CMV infection 13 weeks
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