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

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

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681 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: maribavir

B

Placebo Comparator group

Treatment:

Other: placebo