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CompletedNCT00223925Updated May 13, 2021

Maribavir for Prevention of CMV After Stem Cell Transplants

A Phase 2 interventional study of Maribavir and Placebo in Cytomegalovirus Infection, sponsored by Shire. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-13.

Sponsored by Shire · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2004, registered Sep 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Cytomegalovirus Infection

Keywords

  • Stem cell transplantation
  • Allogeneic transplantation
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In context

Cytomegalovirus Infections

359 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.

This study's enrollment of 111 is above the median of 60 across 233 interventional studies indexed under Cytomegalovirus Infections.

Browse Cytomegalovirus Infections studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Allogeneic stem cell transplant recipient
  • Recipient CMV seropositive
  • Have transplant engraftment
  • Able to swallow tablets

Exclusion criteria

Exclusion Criteria:

  • CMV organ disease
  • HIV infection
  • Use of other anti-CMV therapy post-transplant
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
111 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Maribavir (100 mg twice daily)

    Drug: Maribavir

  • Experimental
    Maribavir (400 mg twice daily)

    Drug: Maribavir

  • Experimental
    Maribavir (400 mg once daily)

    Drug: Maribavir

Interventions

  • DrugMaribavir
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Clinical safety as measured by the recording of treatment emergent adverse events

    Time frame: 13 weeks

Secondary outcomes

  1. Incidence of CMV disease

    Time frame: 13 weeks

  2. Incidence of CMV infection

    Time frame: 13 weeks

07

Study locations

13 sites
  • City of Hope Medical Center
    Duarte, California, United States
  • UCLA Medical Center
    Los Angeles, California, United States
  • Loyola University
    Maywood, Illinois, United States
  • Tufts-New England Medical Center
    Boston, Massachusetts, United States
  • Wayne State Medical Center
    Detroit, Michigan, United States
  • University of Minnesota
    Minneapolis, Minnesota, United States
  • Washington University School of Medicine
    Saint Louis, Missouri, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York, United States
  • Duke Medical Center
    Durham, North Carolina, United States
  • Baylor University Medical Center
    Dallas, Texas, United States
  • MD Anderson Cancer Center
    Houston, Texas, United States
  • University of Utah
    Salt Lake City, Utah, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington, United States
08

References and documents

Publications

  • Winston DJ, Young JA, Pullarkat V, Papanicolaou GA, Vij R, Vance E, Alangaden GJ, Chemaly RF, Petersen F, Chao N, Klein J, Sprague K, Villano SA, Boeckh M. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood. 2008 Jun 1;111(11):5403-10. doi: 10.1182/blood-2007-11-121558. Epub 2008 Feb 19. PubMed 18285548 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00223925
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Oct 28, 2004
Primary completion
Apr 5, 2006
Completion
Apr 5, 2006
Last update
May 13, 2021

Study contacts

Study Director
study director · Takeda
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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