A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)



Status:Terminated
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:2 - 17
Updated:4/21/2016
Start Date:April 2013
End Date:December 2015

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A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients With Sickle Cell Disease.

The main purpose of the study is to evaluate the efficacy and safety of the study drug known
as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants
with sickle cell disease. The study will also investigate reduction in daily pain in
children who have sickle cell disease.


Inclusion Criteria:

- Have SCD [homozygous sickle cell (HbSS) or hemoglobin (HbS) Beta^0 thalassemia]

- Are participants with SCD who have had ≥2 episodes of vaso-occlusive crisis (VOC) in
the past year

- Have a body weight ≥19 kilograms (kg) and are ≥2 and <18 years of age, inclusive at
the time of screening

- If participants are ≥2 and ≤16 years of age, must have had a transcranial Doppler
within the last year

Exclusion Criteria:

- History of: transient ischemic attack (TIA)/ ischemic or hemorrhagic stroke, severe
head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous
malformation, or aneurysm

- History of abnormal or conditional [velocity in middle or anterior cerebral, or
internal carotid artery ≥170 centimeter per second (cm/sec)] transcranial Doppler
within the last year

- History of, or are undergoing treatment with, chronic red blood cell (RBC)
transfusion therapy

- Are at an increased risk for bleeding complications

- Are receiving chronic treatment with nonsteroidal anti-inflammatory drug (NSAID)s and
cannot be switched to another analgesic
We found this trial at
21
sites
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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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,...
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Atlanta, GA
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Cleveland, OH
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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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Kansas City, MO
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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Philadelphia, Pennsylvania 19134
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Philadelphia, PA
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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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Philadelphia, PA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Bronx, NY
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Brussel,
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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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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Charleston, SC
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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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Chicago, IL
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Cincinnati, Ohio 45229
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Cincinnati, OH
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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Oakland, California 94609
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Oakland, CA
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Palo Alto, California 94304
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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4700 Waters Ave
Savannah, Georgia 31404
(912) 350-8000
Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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Savannah, GA
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311 Martin Luther King Jr Way
Tacoma, Washington 98403
(253) 403-1400
Mary Bridge Children's Hospital and Health Center Mary Bridge Children's Hospital was established in 1955,...
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Tacoma, WA
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Washington, District of Columbia 20060
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Washington,
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