Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
This study has been completed.
Sponsor:
ViroPharma
Information provided by:
ViroPharma
ClinicalTrials.gov Identifier:
NCT00497796
First received: July 5, 2007
Last updated: June 20, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Infections |
Drug: maribavir Drug: ganciclovir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by ViroPharma:
Primary Outcome Measures:
- CMV disease [ Time Frame: 6 months post transplant ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CMV disease [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
- Incidence of CMV infection [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
- Incidence of graft rejection [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
- Incidence of retransplantation [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 100 days and 12 months post-transplant ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 348 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: maribavir
100mg twice a day for 14 weeks.
|
| Active Comparator: 2 |
Drug: ganciclovir
1000mg three times per day for 14 weeks.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497796
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Hide Study LocationsLocations
| United States, Arizona | |
| Mayo Clinic Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| University of California at San Diego | |
| La Jolla, California, United States, 92103 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94143 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Mayo Clinic College of Medicine | |
| Jacksonville, Florida, United States, 32224 | |
| Tampa General | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Northwestern University Medical Center | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| Jewish Hospital Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| Ochsner Clinic | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07101 | |
| United States, New York | |
| NYU School of Medicine | |
| New York, New York, United States, 10016 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| University of Rochester Medical Center- Strong Memorial | |
| Rochester, New York, United States, 14642 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| University of North Carolina, Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Integris Baptist Medical Center | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Oregon Health and Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| VA Pittsburgh Healthcare System | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Methodist Transplant Institute | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Baylor University Medical Center (Dallas) | |
| Dallas, Texas, United States, 75246 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Baylor College of Medicine (Houston) | |
| Houston, Texas, United States, 77030 | |
| UT Memorial Hermann Hospital and Texas Liver Center | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Sciences Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Univeristy of Washington Medical Center | |
| Seattle, Washington, United States, 98195-7110 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
ViroPharma
Investigators
| Study Director: | Stephen A Villano, MD | ViroPharma |
More Information
No publications provided
| Responsible Party: | Stephen Villano, MD, Viropharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00497796 History of Changes |
| Other Study ID Numbers: | 1263-301 |
| Study First Received: | July 5, 2007 |
| Last Updated: | June 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ViroPharma:
|
cytomegalovirus CMV prophylaxis liver liver transplant |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Ganciclovir |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013