Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection



Status:Active, not recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 75
Updated:4/21/2016
Start Date:March 2014

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A Phase 3, Open-Label, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection (Chimerix Study CMX001-304)

This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW)
for the treatment of AdV infection detected during asymptomatic AdV viremia or during
symptomatic AdV infection. After completing a screening assessment to confirm study
eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on
Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will
receive BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2
mg/kg BIW, not-to-exceed a total dose of 200 mg/week.


Inclusion Criteria:

- Patients who have undergone hematopoietic cell transplant (HCT), solid organ
transplant (SOT)

- Have a primary or other severe immunodeficiency which predisposes to rapid
progression to disseminated AdV disease

- Must be able to ingest, absorb and tolerate oral medication

- Willing and able to understand and provide written informed consent. For minors or
those incapable of providing written informed consent (i.e., incapacitated),
understood, written and informed consent must be provided by a parent or legal
guardian or representative.

- To the best of his or her (or parent/guardian) knowledge, willing and able to
participate in all required study activities for the duration of the study.

Exclusion Criteria:

- Females who are pregnant or currently nursing.

- Patients with any other condition that would, in the judgment of the investigator,
put the patient at increased risk during participation in the study, or interfere
with the conduct of the study.
We found this trial at
34
sites
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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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...
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Chicago, IL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Atlanta, GA
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Boston, Massachusetts 02215
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Bronx, New York 10467
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Charlotte, North Carolina 28204
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cincinnatti, Ohio 45229
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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...
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Houston, Texas 77030
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Memphis, Tennessee 38105
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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New Orleans, Louisiana 70118
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Omaha, Nebraska 68198
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Palo Alto, California 94305
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84103
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Seattle, Washington 19024
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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St. Louis, Missouri 63108
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Washington, District of Columbia 20010
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