Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients



Status:Completed
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:July 2012
End Date:December 2014

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A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients

This study will assess safety, antiviral activity, and pharmacokinetics of different doses
of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are
resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in
recipients of stem cell or solid organ transplants.


Inclusion Criteria

1. Be ≥12 years of age.

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

1. Be receiving any other anti-CMV agent(s).

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.
We found this trial at
32
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
414
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
435
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
643
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
270
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Chicago, IL
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
2
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
481
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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2007
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Seattle, WA
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
2006
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Seattle, WA
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
831
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
164
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Ann Arbor, MI
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
345
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chicago, Illinois 60611
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Denver, Colorado 80210
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Detroit, Michigan
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
352
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205 Matherly hall
Gainsville, Florida 32611
713
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Gainsville, FL
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
1982
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Los Angeles, CA
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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Nashville, Tennessee 37212
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New Haven, Connecticut 6520
(203) 432-4771
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New Orleans, Louisiana 70121
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Omaha, Nebraska 68198
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
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Pittsburg, Pennsylvania
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San Antonio, Texas 78229
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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Winston Salem, North Carolina 27157
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Worcester, Massachusetts 01655
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