Clinical trial NCT00497796: Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
Official title: A Randomized, Double-blind Study To Assess The Efficacy And Safety Of Prophylactic Use Of Maribavir Versus Oral Ganciclovir For The Prevention Of Cytomegalovirus Disease In Recipients Of Orthotopic Liver Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Infections
Keywords: cytomegalovirus
CMV
prophylaxis
liver
liver transplant
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 307
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: The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.

Detailed description: 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 efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 14 weeks following orthotopic liver transplantation.

Eligibility criteria: Inclusion Criteria:

* Orthotopic liver transplant recipient
* Donor CMV seropositive / Recipient CMV seronegative
* Enrolled within 10 days after liver transplant
* Able to swallow tablets

Exclusion Criteria:

* Multiple organ transplant
* HIV infection
* CMV disease
* Use of other anti-CMV therapy at time of enrollment

Primary outcomes:
measure: Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
timeFrame: 6 months post-transplant
Secondary outcomes:
measure: Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
timeFrame: 6 months post-transplant
measure: Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
timeFrame: 6 months post-transplant
measure: Number of Participants With Investigator-determined CMV Disease
timeFrame: Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant)
measure: Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation
timeFrame: 100 days post-transplant
measure: Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
timeFrame: 100 days post-transplant
measure: Number of Participants With Retransplantation
timeFrame: Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)
measure: Number of Participants With Graft Failure Related Death
timeFrame: Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)
measure: Number of Participants With Acute Graft Rejection
timeFrame: 26 weeks post-transplant
measure: Number of Participants Who Died Within 6 Months Post-Transplantation
timeFrame: 6 months post-transplant
measure: Percent of Participants With Signs of Bone Marrow Suppression
timeFrame: 15 weeks
measure: Plasma Concentration of Maribavir During Treatment
timeFrame: 12 hours post-dose after 2, 6, and 10 weeks of treatment
measure: Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment
timeFrame: 12 hours post-dose after 2, 6, and 10 weeks of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: La Jolla
country: United States
facility: University of California at San Diego
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic College of Medicine
state: Florida
city: Tampa
country: United States
facility: Tampa General
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center- Strong Memorial
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Methodist Transplant Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center (Dallas)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine (Houston)
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Houston
country: United States
facility: UT Memorial Hermann Hospital and Texas Liver Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center at San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Univeristy of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: