Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00411645
First received: December 12, 2006
Last updated: July 21, 2014
Last verified: March 2014

December 12, 2006
July 21, 2014
December 2006
November 2008   (final data collection date for primary outcome measure)
CMV organ disease [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: No ]
CMV organ disease at 6 months post-transplant
Complete list of historical versions of study NCT00411645 on ClinicalTrials.gov Archive Site
  • CMV organ disease [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
  • Incidence of CMV infection [ Time Frame: 100 days, 6 months, and 12 months post-transplant ] [ Designated as safety issue: No ]
  • Incidence of graft-versus-host disease [ Time Frame: 100 days and 6 months post-transplant ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 100 days, 6 months, and 12 months post-transplant ] [ Designated as safety issue: No ]
  • CMV organ disease at 100 days and 12 months post-transplant
  • Incidence of CMV infection
  • Incidence of graft-versus-host disease
  • Mortality
Not Provided
Not Provided
 
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.

The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.

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 12 weeks following allogeneic stem cell transplant.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Cytomegalovirus Infections
  • Drug: maribavir
    100 mg twice daily for up to 12 weeks
  • Other: placebo
    twice daily for up to 12 weeks
  • Experimental: A
    Intervention: Drug: maribavir
  • Placebo Comparator: B
    Intervention: Other: placebo
Marty FM, Ljungman P, Papanicolaou GA, Winston DJ, Chemaly RF, Strasfeld L, Young JA, Rodriguez T, Maertens J, Schmitt M, Einsele H, Ferrant A, Lipton JH, Villano SA, Chen H, Boeckh M; Maribavir 1263-300 Clinical Study Group. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2011 Apr;11(4):284-92. doi: 10.1016/S1473-3099(11)70024-X. Epub 2011 Mar 21. Erratum in: Lancet Infect Dis. 2011 May;11(5):343.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
May 2009
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • CMV organ disease
  • HIV infection
  • Use of other anti-CMV therapy post-transplant
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden,   Belgium,   Spain,   United States,   Italy,   France,   United Kingdom,   Germany,   Canada
 
NCT00411645
1263-300, 2006-005692-18
Yes
Stephen Villano, MD, ViroPharma Incorporated
Shire
Not Provided
Study Director: Stephen A Villano, MD ViroPharma
Shire
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP