Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
NCT ID: NCT00497796
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
307 participants
INTERVENTIONAL
2007-07-23
2009-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
maribavir
100mg twice a day for 14 weeks.
2
ganciclovir
1000mg three times per day for 14 weeks.
Interventions
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maribavir
100mg twice a day for 14 weeks.
ganciclovir
1000mg three times per day for 14 weeks.
Eligibility Criteria
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Inclusion Criteria
* Donor CMV seropositive / Recipient CMV seronegative
* Enrolled within 10 days after liver transplant
* Able to swallow tablets
Exclusion Criteria
* HIV infection
* CMV disease
* Use of other anti-CMV therapy at time of enrollment
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
University of California at San Diego
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Mayo Clinic College of Medicine
Jacksonville, Florida, United States
Tampa General
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University Medical Center
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Jewish Hospital Louisville
Louisville, Kentucky, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
NYU School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center- Strong Memorial
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist Transplant Institute
Memphis, Tennessee, United States
Baylor University Medical Center (Dallas)
Dallas, Texas, United States
Baylor College of Medicine (Houston)
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
UT Memorial Hermann Hospital and Texas Liver Center
Houston, Texas, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Univeristy of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
Other Identifiers
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2007-004729-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP620-301
Identifier Type: OTHER
Identifier Source: secondary_id
1263-301
Identifier Type: -
Identifier Source: org_study_id
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