NCT00411645

Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 681 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	maribavir	100 mg twice daily for up to 12 weeks
OTHER	placebo	twice daily for up to 12 weeks

Timeline

• Start date: 2006-12-13
• Primary completion: 2008-11-10
• Completion: 2009-05-23
• First posted: 2006-12-14
• Last updated: 2021-06-11
• Results posted: 2015-06-03

Locations

97 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Spain, Sweden, United Kingdom