Maribavir for Prevention of CMV After Stem Cell Transplants

Shire

Status and phase: Completed; Phase 2

Conditions: Cytomegalovirus Infection

Treatments: Drug: Maribavir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00223925

1263-200

Details and patient eligibility

About

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 anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Allogeneic stem cell transplant recipient
• Recipient 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: Double Blind

---

111 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Maribavir (100 mg twice daily)

Experimental group

Treatment:

Drug: Maribavir

Maribavir (400 mg twice daily)

Experimental group

Treatment:

Drug: Maribavir

Maribavir (400 mg once daily)

Experimental group

Treatment:

Drug: Maribavir