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

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Shire

Status and phase

Completed
Phase 3

Conditions

Cytomegalovirus Infections

Treatments

Other: placebo
Drug: maribavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00411645
2006-005692-18 (EudraCT Number)
SHP620-300 (Other Identifier)
1263-300

Details and patient eligibility

About

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.

Full 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.

Enrollment

681 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

681 participants in 2 patient groups, including a placebo group

A
Experimental group
Treatment:
Drug: maribavir
B
Placebo Comparator group
Treatment:
Other: placebo

Trial contacts and locations

97

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Data sourced from clinicaltrials.gov

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