Clinical trial NCT00223925: Maribavir for Prevention of CMV After Stem Cell Transplants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cytomegalovirus Infection
Keywords: Stem cell transplantation
Allogeneic transplantation
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical safety as measured by the recording of treatment emergent adverse events
timeFrame: 13 weeks
Secondary outcomes:
measure: Incidence of CMV disease
timeFrame: 13 weeks
measure: Incidence of CMV infection
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Boston
country: United States
facility: Tufts-New England Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.