NCT00223925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2006

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

September 13, 2005

Last Update Submit

May 11, 2021

Conditions

Cytomegalovirus Infection

Keywords

Stem cell transplantationAllogeneic transplantation

Outcome Measures

Primary Outcomes (1)

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

    13 weeks

Secondary Outcomes (2)

  • Incidence of CMV disease

    13 weeks

  • Incidence of CMV infection

    13 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Maribavir (100 mg twice daily)

EXPERIMENTAL
Drug: Maribavir

Maribavir (400 mg twice daily)

EXPERIMENTAL
Drug: Maribavir

Maribavir (400 mg once daily)

EXPERIMENTAL
Drug: Maribavir

Interventions

MaribavirDRUG
Maribavir (100 mg twice daily)Maribavir (400 mg once daily)Maribavir (400 mg twice daily)
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

City of Hope Medical Center

Duarte, California, United States

Location

UCLA Medical Center

Los Angeles, California, United States

Location

Loyola University

Maywood, Illinois, United States

Location

Tufts-New England Medical Center

Boston, Massachusetts, United States

Location

Wayne State Medical Center

Detroit, Michigan, United States

Location

University of Minnesota

Minneapolis, Minnesota, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Location

Duke Medical Center

Durham, North Carolina, United States

Location

Baylor University Medical Center

Dallas, Texas, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

University of Utah

Salt Lake City, Utah, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Location

Related Publications (1)

  • 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.

    PMID: 18285548DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

maribavir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

October 28, 2004

Primary Completion

April 5, 2006

Study Completion

April 5, 2006

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations

US(13)