Now Recruiting

Efficacy and Safety Study of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

WHAT IS THE PURPOSE OF THIS STUDY?

The purpose of this study is to compare the efficacy of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant (HSCT) recipients.

TRIAL AT A GLANCE

Condition

Cytomegalovirus (CMV)

Study Intervention

Maribavir; Valganciclovir; Placebo

Possibility of Active Treatment

100%

Study Type

Interventional

Phase

Phase 3

IS THIS STUDY RIGHT FOR ME?

AGE

16 & UP

N/A

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

PARTICIPATION DURATION/ REQUIREMENTS

Planned duration of screening phase: 2 weeks, planned duration of treatment phase: 8 weeks, planned duration of follow-up phase: 12 weeks. All patients who meet the eligibility requirements during the screening phase will be randomly selected to receive either maribavir or valganciclovir during the 8 week treatment phase. This study requires approximately 18 visits to the study site.

ENTRY CRITERIA

Recipient of hematopoietic stem cell transplant

Have a documented asymptomatic CMV infection

If presenting with recurrent CMV infection, have at least 2 weeks of undetectableCMV DNA

Must not have a CMV infection that is known to be genotypically resistant to ganciclovir,valganciclovir, foscarnet, or cidofovir

Must not require ganciclovir, valganciclovir, foscarnet, or cidofovir administration forconditions other than CMV when study treatment is initiated

Must not be receiving leflunomide, or artesunate when study treatment is initiated

Must not be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet orcidofovir) for the current CMV infection for longer than 72 hours.

Study Locations

We are planning* on conducting this study in 18 countries around the world.

    • Australia
    • Belgium
    • Canada
    • Croatia
    • Czech Republic
    • France
    • Germany
    • Hungary
    • Italy
    • Korea (Republic of)
    • New Zealand
    • Poland
    • Singapore
    • Spain
    • Switzerland
    • Turkey
    • United Kingdom
    • United States of America

Enter your city or postal code to find a location near you.

RESULTS

*Planning is an intent to conduct this study in the specified countries and is subject to change.