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Maribavir for Prevention of CMV After Stem Cell Transplants

Primary Purpose

Cytomegalovirus Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Maribavir
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Infection focused on measuring Stem cell transplantation, Allogeneic transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Allogeneic stem cell transplant recipient Recipient CMV seropositive Have transplant engraftment Able to swallow tablets Exclusion Criteria: CMV organ disease HIV infection Use of other anti-CMV therapy post-transplant

Sites / Locations

  • City of Hope Medical Center
  • UCLA Medical Center
  • Loyola University
  • Tufts-New England Medical Center
  • Wayne State Medical Center
  • University of Minnesota
  • Washington University School of Medicine
  • Memorial Sloan-Kettering Cancer Center
  • Duke Medical Center
  • Baylor University Medical Center
  • MD Anderson Cancer Center
  • University of Utah
  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Maribavir (100 mg twice daily)

Maribavir (400 mg twice daily)

Maribavir (400 mg once daily)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of CMV disease
Incidence of CMV infection

Full Information

First Posted
September 13, 2005
Last Updated
May 11, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00223925
Brief Title
Maribavir for Prevention of CMV After Stem Cell Transplants
Official Title
A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2004 (Actual)
Primary Completion Date
April 5, 2006 (Actual)
Study Completion Date
April 5, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection
Keywords
Stem cell transplantation, Allogeneic transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Maribavir (100 mg twice daily)
Arm Type
Experimental
Arm Title
Maribavir (400 mg twice daily)
Arm Type
Experimental
Arm Title
Maribavir (400 mg once daily)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Maribavir
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical safety as measured by the recording of treatment emergent adverse events
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Incidence of CMV disease
Time Frame
13 weeks
Title
Incidence of CMV infection
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Allogeneic stem cell transplant recipient Recipient CMV seropositive Have transplant engraftment Able to swallow tablets Exclusion Criteria: CMV organ disease HIV infection Use of other anti-CMV therapy post-transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
Country
United States
Facility Name
Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Wayne State Medical Center
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18285548
Citation
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.
Results Reference
derived

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Maribavir for Prevention of CMV After Stem Cell Transplants

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