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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose through 24 months

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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