Phase 2
Completed N=33
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease
Source: ClinicalTrials.gov NCT01476696 ↗Enrolled (actual)
33
Serious AEs
9.5%
Results posted
Dec 2013
Primary outcomePrimary: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM) — 8.68; 14.5; 20.8; 31.3 nanograms*hour per milliliter (ng*hr/mL)
Summary
The purpose of this study is to determine the correct prasugrel dosage to be given to children with sickle cell disease (SCD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM) |
8.68; 14.5; 20.8; 31.3; 22.2; 50.3 | — |
| PRIMARY Percentage of Platelet Inhibition as Measured by VerifyNow™P2Y12 (VN) |
2.0; 0.0; 0.0; 7.7; 2.5; 0.0 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite |
— | — |
| SECONDARY Number of Participants With Pain |
6; 4; 1; 2 | — |
| SECONDARY Number of Participants With Hemorrhagic Events Requiring Medical Intervention |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT01476696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.