Circulatory System Paediatrics Sickle Cell Disease
Conditions
Interventions
Prasugrel
Placebo
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Are patients with SCD (laboratory determined HbSS or HbS beta zero thalassemia) who have had ¿2 episodes of VOC in the past year [2] Have a body weight ¿19 kg and are ¿2 and <18 years of age, inclusive at the time of screening for the double-blind treatment period [3] If patients are ¿2 and ¿16 years of age, must have had a transcranial Doppler within the last year [4] Use of hydroxyurea is permitted under this protocol if the patient has been on a stable dose for the 60 days prior to randomization without signs of hematologic toxicity within 60 days of screening (see Section 9.8). [5] 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. [6] If sexually active, patients agree to use a reliable method of birth control during the study until 1 month following the last dose of study drug. Females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
Exclusion criteria
Exclusion criteria: (7)Vaso-occlusive crisis (requiring medical intervention) within 15 days prior to screening [8] Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival. [9] Hepatic dysfunction characterized by alanine aminotransferase (ALT) ¿3 x upper limit of normal (ULN) [10] Renal dysfunction requiring chronic dialysis or creatinine ¿1.2 mg/dL [11] Contraindication for antiplatelet therapy [12] History of intolerance or allergy to approved thienopyridines [13] Patients with a hematocrit 300 RBC/high-powered field (HPF) on urinalysis at the time of screening [20] History of vitreous hemorrhage or proliferative retinopathy [21] Any of the following: ¿ History of TIA/ ischemic or hemorrhagic stroke ¿ Intracranial neoplasm, arteriovenous malformation, or aneurysm ¿ History of severe head trauma ¿ History of intracranial hemorrhage [22] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding [23] Platelet count <100,000 per ¿L of blood [24] Have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days [25] History of dysfunctional uterine bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of prasugrel compared to placebo in in pediatric patients with SCD | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term safety safety of prasugrel in pediatric patients with SCD;Long term efficacy of prasugrel in pediatric patients with SCD | — |
Countries
Ghana, Kenya
Contacts
Public ContactElbe Wessels
Clinical Project Manager
Outcome results
None listed