Maribavir for Prevention of CMV After Stem Cell Transplants

May 11, 2021 updated by: Shire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States
        • City of Hope Medical Center
      • Los Angeles, California, United States
        • UCLA Medical Center
    • Illinois
      • Maywood, Illinois, United States
        • Loyola University
    • Massachusetts
      • Boston, Massachusetts, United States
        • Tufts-New England Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • Wayne State Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
    • New York
      • New York, New York, United States
        • Memorial Sloan-Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States
        • Duke Medical Center
    • Texas
      • Dallas, Texas, United States
        • Baylor University Medical Center
      • Houston, Texas, United States
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah
    • Washington
      • Seattle, Washington, United States
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: Maribavir (100 mg twice daily)
Drug: Maribavir
EXPERIMENTAL: Maribavir (400 mg twice daily)
Drug: Maribavir
EXPERIMENTAL: Maribavir (400 mg once daily)
Drug: Maribavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical safety as measured by the recording of treatment emergent adverse events
Time Frame: 13 weeks
13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of CMV disease
Time Frame: 13 weeks
13 weeks
Incidence of CMV infection
Time Frame: 13 weeks
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 28, 2004

Primary Completion (ACTUAL)

April 5, 2006

Study Completion (ACTUAL)

April 5, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1263-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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