Maribavir for Prevention of CMV After Stem Cell Transplants

NCT ID: NCT00223925

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-28

Study Completion Date

2006-04-05

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Maribavir (100 mg twice daily)

Group Type EXPERIMENTAL

Maribavir

Intervention Type DRUG

Maribavir (400 mg twice daily)

Group Type EXPERIMENTAL

Maribavir

Intervention Type DRUG

Maribavir (400 mg once daily)

Group Type EXPERIMENTAL

Maribavir

Intervention Type DRUG

Interventions

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Maribavir

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Loyola University

Maywood, Illinois, United States

Site Status

Tufts-New England Medical Center

Boston, Massachusetts, United States

Site Status

Wayne State Medical Center

Detroit, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Duke Medical Center

Durham, North Carolina, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18285548 (View on PubMed)

Other Identifiers

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1263-200

Identifier Type: -

Identifier Source: org_study_id

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