Conditions: Cytomegalovirus Infections
Keywords: prevention prophylaxis Cytomegalovirus CMV allogeneic stem cell transplant SCT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 681
Healthy volunteers: no

Brief summary:
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.

Detailed description:
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 efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: maribavir intervention 2: placebo
Intervention descriptions: intervention 1: 100 mg twice daily for up to 12 weeks intervention 2: twice daily for up to 12 weeks

Protocol document: