Maribavir for Prevention of CMV After Stem Cell Transplants

A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223925

Enrollment

111

Registered

2005-09-22

Start date

2004-10-28

Completion date

2006-04-05

Last updated

2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infection

Keywords

Stem cell transplantation, Allogeneic transplantation

Brief summary

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.

Interventions

DRUGMaribavir

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Clinical safety as measured by the recording of treatment emergent adverse events	13 weeks

Secondary

Measure	Time frame
Incidence of CMV disease	13 weeks
Incidence of CMV infection	13 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026