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Prasugrel for Sickle Cell Disease

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose through 24 months
Awards & highlights

Summary

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.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose through 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose through 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC)
Secondary study objectives
Pain
Monthly Rate of Days With Pain
Monthly Rate of Days of Analgesic Use
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrasugrelExperimental Treatment1 Intervention
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prasugrel
FDA approved

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
404 Previous Clinical Trials
447,603 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,650 Previous Clinical Trials
3,223,425 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
422,331 Total Patients Enrolled
~27 spots leftby Sep 2025
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