A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease

Completed · Phase 2

Conditions studied: Sickle Cell Disease

In brief

The purpose of this study is to determine the correct prasugrel dosage to be given to children with sickle cell disease (SCD).

Key facts

Study ID: NCT01476696
Run by: Eli Lilly and Company
People needed: 33
Starts: 2011-11-01
Expected to finish: 2012-11-01
Last updated by the study team: 2014-02-13

Who can join

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

You may qualify if…

Are male or female with SCD [(homozygous sickle cell (HbSS) and hemoglobin S beta \^0 thalassemia (HbS β\^0 thalassemia)]
Have a body weight ≥12 kilograms (kg) and are ≥2 to <18 years of age at the time of screening
If participants are ≥2 and ≤16 years of age, have had a transcranial Doppler within the last year
Participants on hydroxyurea must be on a stable dose for the 60 days prior to enrollment without signs of hematologic toxicity at screening
Have a legal representative that is in competent mental condition to provide written informed consent on behalf of the study participant before entering the study. The child may be required to give documented assent, if required by local regulations.
If sexually active, has a negative pregnancy test at screening (if female) and agrees to use a reliable method of birth control during the study (for both males and females)

You may not qualify if…

Known to have hemoglobin C sickle cell (HbSC) or hemoglobin S beta \^plus thalassemia (HbS β\^+ thalassemia) genotypes
Vaso-occlusive crisis (VOC) requiring medical attention within 15 days prior to screening
Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival
Hepatic dysfunction characterized by alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN)
Renal dysfunction requiring chronic dialysis or creatinine ≥ 1.5 milligrams per deciliter (mg/dL)
Contraindication for antiplatelet therapy
History of intolerance or allergy to approved thienopyridines (clopidogrel, ticlopidine, or prasugrel)
Participants with a hematocrit <18%
History of abnormal or conditional transcranial Doppler [velocity in middle cerebral or carotid artery ≥170 centimeters per second (cm/sec)] within the last year
Any history of bleeding diathesis
Any history of renal papillary necrosis
Active internal bleeding
History of spontaneous gastrointestinal bleeding
Gross hematuria or > 300 red blood cells (RBC)/high-powered field (HPF) on urinalysis at the time of screening
Any history of vitreous hemorrhage
Prior history of hemorrhagic or ischemic stroke, a transient ischemic attack (TIA), or other intracranial hemorrhage
Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
Platelet count <100,000 per microliter (μl) of blood
Have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days
History of dysfunctional uteral bleeding, in the judgment of the investigator
Treatment with packed RBC or whole blood transfusion therapy within 30 days prior to dosing
Any nonsteroidal anti-inflammatory drug (NSAID) use within 5 days prior to screening
Any aspirin, warfarin, thienopyridine, or other antiplatelet medication use within 10 days prior to dosing
Anticipated use of aspirin, warfarin, thienopyridine, or other antiplatelet medication during the study period

Where it is running

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. — Oakland, California, 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. — Washington D.C., District of Columbia, 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. — Chicago, Illinois, 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. — New Orleans, Louisiana, 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. — Boston, Massachusetts, 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. — St Louis, Missouri, 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. — Chapel Hill, North Carolina, 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. — Cincinnati, Ohio, 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. — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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