Status:
COMPLETED
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the correct prasugrel dosage to be given to children with sickle cell disease (SCD).
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01476696
Start Date
November 1 2011
End Date
November 1 2012
Last Update
February 13 2014
Active Locations (9)
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1
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, 94609
2
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, 20060
3
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, 60614
4
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, 70112