Maribavir for Prevention of CMV After Stem Cell Transplants

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00223925
• Collaborator: (none)
• Enrollment: 111
• Locations: 13
• Arms: 4
• Actual Duration (Months): 17.2
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Infection	Drug: Maribavir; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Oct 28, 2004
• Actual Primary Completion Date: Apr 5, 2006
• Actual Study Completion Date: Apr 5, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical safety as measured by the recording of treatment emergent adverse events [13 weeks]

Secondary Outcome Measures

1. Incidence of CMV disease [13 weeks]

2. Incidence of CMV infection [13 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Medical Center	Duarte	California	United States
2	UCLA Medical Center	Los Angeles	California	United States
3	Loyola University	Maywood	Illinois	United States
4	Tufts-New England Medical Center	Boston	Massachusetts	United States
5	Wayne State Medical Center	Detroit	Michigan	United States
6	University of Minnesota	Minneapolis	Minnesota	United States
7	Washington University School of Medicine	Saint Louis	Missouri	United States
8	Memorial Sloan-Kettering Cancer Center	New York	New York	United States
9	Duke Medical Center	Durham	North Carolina	United States
10	Baylor University Medical Center	Dallas	Texas	United States
11	MD Anderson Cancer Center	Houston	Texas	United States
12	University of Utah	Salt Lake City	Utah	United States
13	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT00223925
• Other Study ID Numbers: 1263-200
• First Posted: Sep 22, 2005
• Last Update Posted: May 13, 2021
• Last Verified: May 1, 2021

• Keywords provided by Shire: Stem cell transplantation; Allogeneic transplantation
• Additional relevant MeSH terms: Cytomegalovirus Infections; Maribavir

Study Results

No Results Posted as of May 13, 2021