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:

ViroPharma

ClinicalTrials.gov Identifier:

NCT00411645

First received: December 12, 2006

Last updated: June 20, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2006

Last Updated Date

June 20, 2011

Start Date ^ICMJE

December 2006

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

CMV organ disease at 6 months post-transplant

Change History

Complete list of historical versions of study NCT00411645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

CMV organ disease at 100 days and 12 months post-transplant
Incidence of CMV infection
Incidence of graft-versus-host disease
Mortality

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Cytomegalovirus Infections

Intervention ^ICMJE

Drug: maribavir
100 mg twice daily for up to 12 weeks
Other: placebo
twice daily for up to 12 weeks

Study Arm (s)

Experimental: A
Intervention: Drug: maribavir
Placebo Comparator: B
Intervention: Other: placebo

Publications *

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. Epub 2011 Mar 21.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

613

Completion Date

May 2009

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, France, Germany, Italy, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00411645

Other Study ID Numbers ^ICMJE

1263-300

Has Data Monitoring Committee

Yes

Responsible Party

Stephen Villano, MD, ViroPharma Incorporated

Study Sponsor ^ICMJE

ViroPharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Stephen A Villano, MD

ViroPharma

Information Provided By

ViroPharma

Verification Date

June 2011

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

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