Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients

Shire

Status and phase: Completed; Phase 3

Conditions: Cytomegalovirus Infections

Treatments: Drug: ganciclovir; Drug: maribavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00497796

2007-004729-16 (EudraCT Number)

SHP620-301 (Other Identifier)

1263-301

Details and patient eligibility

About

The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver 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 14 weeks following orthotopic liver transplantation.

Enrollment: 307 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Orthotopic liver transplant recipient
• Donor CMV seropositive / Recipient CMV seronegative
• Enrolled within 10 days after liver transplant
• Able to swallow tablets

Exclusion criteria

• Multiple organ transplant
• HIV infection
• CMV disease
• Use of other anti-CMV therapy at time of enrollment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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307 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: maribavir

2

Active Comparator group

Treatment:

Drug: ganciclovir