Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
NCT ID: NCT01611974
Last Updated: 2021-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2012-07-17
2014-12-05
Brief Summary
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Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Maribavir 400 mg twice daily
Maribavir
Tablet for oral administration
Maribavir 800 mg twice daily
Maribavir
Tablet for oral administration
Maribavir 1200 mg twice daily
Maribavir
Tablet for oral administration
Interventions
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Maribavir
Tablet for oral administration
Eligibility Criteria
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Inclusion Criteria
2. Weigh ≥ 40 kg.
3. Be a recipient of stem cell or solid organ transplantation.
4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA copies/mL.
5. Have a current CMV infection that is resistant (known CMV genetic mutations) or refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir and/or foscarnet.
6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test prior to randomization.
7. Be able to swallow tablets.
8. If adult, provide written informed consent. If child (age \<18 years), have a parent/legal guardian who is willing and able to provide written informed consent (with assent from the child when appropriate).
9. Be assessed by the investigator to determine whether prophylaxis for non-CMV herpesvirus infections (e.g., herpes simplex virus \[HSV type 1 and type 2\] and varicella zoster virus \[VZV\]) is appropriate according to institutional guidelines or standard practices, keeping in mind that maribavir is not active in vitro against these viruses.
Exclusion Criteria
2. Have a current CMV infection that is considered resistant or refractory due to inadequate adherence to prior oral anti-CMV treatment.
3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the time of enrollment.
4. Have severe hepatic impairment.
5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
6. Have expected survival less than 6 weeks.
7. Be pregnant or breastfeeding.
8. Other clinically significant medical or surgical condition.
12 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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UCLA Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health Care System
Detroit, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
University of Nebraska
Omaha, Nebraska, United States
Columbia University
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Methodist Healthcare System
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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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.
Sun K, Fournier M, Sundberg AK, Song IH. Maribavir: Mechanism of action, clinical, and translational science. Clin Transl Sci. 2024 Jan;17(1):e13696. doi: 10.1111/cts.13696.
Chou S, Song K, Wu J, Bo T, Crumpacker C. Drug Resistance Mutations and Associated Phenotypes Detected in Clinical Trials of Maribavir for Treatment of Cytomegalovirus Infection. J Infect Dis. 2022 Sep 4;226(4):576-584. doi: 10.1093/infdis/jiaa462.
Papanicolaou GA, Silveira FP, Langston AA, Pereira MR, Avery RK, Uknis M, Wijatyk A, Wu J, Boeckh M, Marty FM, Villano S. Maribavir for Refractory or Resistant Cytomegalovirus Infections in Hematopoietic-cell or Solid-organ Transplant Recipients: A Randomized, Dose-ranging, Double-blind, Phase 2 Study. Clin Infect Dis. 2019 Apr 8;68(8):1255-1264. doi: 10.1093/cid/ciy706.
Schubert A, Ehlert K, Schuler-Luettmann S, Gentner E, Mertens T, Michel D. Fast selection of maribavir resistant cytomegalovirus in a bone marrow transplant recipient. BMC Infect Dis. 2013 Jul 19;13:330. doi: 10.1186/1471-2334-13-330.
Other Identifiers
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SHP620-202
Identifier Type: OTHER
Identifier Source: secondary_id
1263-202
Identifier Type: -
Identifier Source: org_study_id
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