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
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Shire |
United States,
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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