A Phase 3 study for the Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease

A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003837-41-GB

Enrollment

220

Registered

2013-01-25

Start date

2013-04-15

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease MedDRA version: 16.0 Level: LLT Classification code 10040644 Term: Sickle cell disease System Organ Class: 100000004850

Interventions

Product Name: Prasugrel hydrochloride Product Code: LY640315 Pharmaceutical Form: Tablet INN or Proposed INN: PRASUGREL CAS Number: 389574-19-0 Current Sponsor code: LY640315 Other descriptive name: P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. Have SCD (HbSS or HbS0 thalassemia) b. Are patients with SCD who have had =2 episodes of VOC (vaso-occlusive crisis) in the past year c. Have a body weight =12 kg and are =2 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a. History of: TIA/ ischemic or hemorrhagic stroke, severe head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm b. History of abnormal or conditional (velocity in middle or anterior cerebral, or internal carotid artery =170 cm/sec) transcranial Doppler within the last year c. History of, or are undergoing treatment with, chronic RBC transfusion therapy d. Are at an increased risk for bleeding complications e. Are receiving treatment with oral NSAIDs exceeding 4 days per week or intravenous NSAIDs exceeding 2 days per week

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD as measured by reduction in the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome, throughout the study.;Secondary Objective: Major Secondary Efficacy Objectives • Assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD by assessment of the following key endpoints: 1. the reduction in the rate and intensity of sickle cell-related pain as recorded in patient pain diaries 2. the reduction in the rate of hospitalization for VOC Safety Objectives: • Assess the safety of prasugrel compared to placebo in pediatric patients with SCD.;Primary end point(s): The primary objective of this study is to test the hypothesis that prasugrel compared to placebo will reduce the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome.;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD as measured by reduction in the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome, throughout the study.;Secondary Objective: Major Secondary Efficacy Objectives • Assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD by assessment of the following key endpoints: 1. the reduction in the rate and intensity of sickle cell-related pain as recorded in patient pain diaries 2. the reduction in the rate of hospitalization for VOC Safety Objectives: • Assess the safety of prasugrel compared to placebo in pediatric patients with SCD.;Primary end point(s): The primary objective of this study is to test the hypothesis that prasugrel compared to placebo will reduce the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome.;Timepoint(s) of evaluation of this end point: 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): Major secondary efficacy measures include: • Rate and intensity of sickle cell-related pain as recorded in patient pain diaries • Rate of hospitalization for VOC ;Timepoint(s) of evaluation of this end point: 36 months (3 years)	—

Countries

Belgium, Brazil, Canada, Egypt, France, Ghana, Italy, Kenya, Lebanon, Netherlands, Oman, Saudi Arabia, Turkey, United Arab Emirates, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026