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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.

Phase 3
18 Years
Not Enrolling
Cytomegalovirus Infections

Thank you

Trial Information

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.

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

Inclusion Criteria:

- Allogeneic stem cell transplant recipient

- Recipient or donor 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:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

CMV organ disease

Outcome Time Frame:

6 months post-transplant

Safety Issue:


Principal Investigator

Stephen A Villano, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

May 2009

Related Keywords:

  • Cytomegalovirus Infections
  • prevention
  • prophylaxis
  • Cytomegalovirus
  • CMV
  • allogeneic stem cell transplant
  • SCT
  • Cytomegalovirus Infections



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