NCT00223925
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Shire
- Enrollment
- 111
- Locations
- 13
- Primary Endpoint
- Clinical safety as measured by the recording of treatment emergent adverse events
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Maribavir (100 mg twice daily)
Experimental
Intervention: Maribavir (Drug)
Maribavir (400 mg twice daily)
Experimental
Intervention: Maribavir (Drug)
Maribavir (400 mg once daily)
Experimental
Intervention: Maribavir (Drug)
Outcomes
Primary Outcomes
Clinical safety as measured by the recording of treatment emergent adverse events
Time Frame: 13 weeks
Secondary Outcomes
- Incidence of CMV disease(13 weeks)
- Incidence of CMV infection(13 weeks)
Investigators
Study Sites (13)
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