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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cytomegalovirus Infection
Both
Cytomegalovirus Infection
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
Safety and tolerabilty for up to 12 weeks of dosing
Authority:
United States: Food and Drug Administration
Study ID:
1263-200
NCT ID:
NCT00223925
Start Date:
Completion Date:
Related Keywords:
- Cytomegalovirus Infection
- Stem cell transplantation
- Allogeneic transplantation
- Cytomegalovirus Infections
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| City of Hope Medical Center | Duarte, California 91010 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| University of Utah | Salt Lake City, Utah |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Loyola University | Maywood, Illinois 60153 |
| Tufts-New England Medical Center | Boston, Massachusetts 02111 |
| Wayne State Medical Center | Detroit, Michigan |
| Duke Medical Center | Durham, North Carolina |
