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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT01794000

Run by

Eli Lilly and Company

People needed

341

Starts

2013-04-01

Expected to finish

2015-12-01

Last updated by the study team

2019-09-25

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Oakland — Oakland, California, United States
• Stanford Univ Medical Center — Palo Alto, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Childrens Hospital of Michigan — Detroit, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• University of NC at Chapel Hill School of Medicine — Chapel Hill, North Carolina, United States
• Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St Christophers Hospital For Children — Philadelphia, Pennsylvania, United States
• Childrens Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• St Jude Childrens Research Hospital — Memphis, Tennessee, United States
• Mary Bridge Children's Hospital and Health Center — Tacoma, Washington, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Brussels, Belgium
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Montegnée, Belgium
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Rio de Janeiro, Brazil
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Montreal, Quebec, Canada
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Al Fayyum, Egypt

Full record on ClinicalTrials.gov

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