Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
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
3 other identifiers
interventional
307
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2007
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2007
CompletedFirst Posted
Study publicly available on registry
July 9, 2007
CompletedStudy Start
First participant enrolled
July 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2009
CompletedResults Posted
Study results publicly available
June 4, 2015
CompletedJune 11, 2021
June 1, 2021
2.1 years
July 5, 2007
May 4, 2015
June 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction \[PCR\] assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell \[WBC\] count \<3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was \>4000/mm3) \>/=24 hours apart, atypical lymphocytosis \>/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
6 months post-transplant
Secondary Outcomes (12)
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
6 months post-transplant
Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation
6 months post-transplant
Number of Participants With Investigator-determined CMV Disease
Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant)
Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation
100 days post-transplant
Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation
100 days post-transplant
- +7 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Orthotopic liver transplant recipient
- Donor CMV seropositive / Recipient CMV seronegative
- Enrolled within 10 days after liver transplant
- Able to swallow tablets
You may not qualify if:
- Multiple organ transplant
- HIV infection
- CMV disease
- Use of other anti-CMV therapy at time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (55)
Mayo Clinic Arizona
Phoenix, Arizona, 85006, United States
University of California at San Diego
La Jolla, California, 92103, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic College of Medicine
Jacksonville, Florida, 32224, United States
Tampa General
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Jewish Hospital Louisville
Louisville, Kentucky, 40202, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
New England Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07101, United States
NYU School of Medicine
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center- Strong Memorial
Rochester, New York, 14642, United States
New York Medical College
Valhalla, New York, 10595, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Methodist Transplant Institute
Memphis, Tennessee, 38104, United States
Baylor University Medical Center (Dallas)
Dallas, Texas, 75246, United States
Baylor College of Medicine (Houston)
Houston, Texas, 77030, United States
Methodist Hospital
Houston, Texas, 77030, United States
UT Memorial Hermann Hospital and Texas Liver Center
Houston, Texas, 77030, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Univeristy of Washington Medical Center
Seattle, Washington, 98195-7110, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
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.
PMID: 39807668DERIVEDVernooij 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.
PMID: 38700045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2007
First Posted
July 9, 2007
Study Start
July 23, 2007
Primary Completion
September 14, 2009
Study Completion
September 14, 2009
Last Updated
June 11, 2021
Results First Posted
June 4, 2015
Record last verified: 2021-06