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
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Infections
Drug: maribavir
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • CMV organ disease [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 613
Study Start Date: December 2006
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: maribavir
100 mg twice daily for up to 12 weeks
Placebo Comparator: B Other: placebo
twice daily for up to 12 weeks

Detailed 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 12 weeks following allogeneic stem cell transplant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411645

  Show 97 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Stephen A Villano, MD ViroPharma
  More Information

No publications provided by Shire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Villano, MD, ViroPharma Incorporated
ClinicalTrials.gov Identifier: NCT00411645     History of Changes
Obsolete Identifiers: NCT00430339
Other Study ID Numbers: 1263-300, 2006-005692-18
Study First Received: December 12, 2006
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
prevention
prophylaxis
Cytomegalovirus
CMV
allogeneic stem cell transplant
SCT

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014