Maribavir for Prevention of CMV After Stem Cell Transplants

Phase 2

Completed

• Conditions: Cytomegalovirus Infection
• Interventions: Drug: Placebo; Drug: Maribavir

• Registration Number: NCT00223925
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-28
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2006-04-05
• Study Completion: 2006-04-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Maribavir (100 mg twice daily)	Maribavir	-
Maribavir (400 mg twice daily)	Maribavir	-
Maribavir (400 mg once daily)	Maribavir	-

Primary Outcome Measures

Name	Time	Method
Clinical safety as measured by the recording of treatment emergent adverse events	13 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of CMV infection	13 weeks
Incidence of CMV disease	13 weeks

Trial Locations

Locations (13)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Loyola University; 🇺🇸 Maywood, Illinois, United States

Duke Medical Center; 🇺🇸 Durham, North Carolina, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Tufts-New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Wayne State Medical Center; 🇺🇸 Detroit, Michigan, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States