A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01794000
• Date of registration: 14/02/2013
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
• Scientific title: A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients With Sickle Cell Disease.
• Date of first enrolment: April 2013
• Target sample size: 341
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01794000
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have SCD [homozygous sickle cell (HbSS) or hemoglobin (HbS) Beta^0 thalassemia]

- Are participants with SCD who have had =2 episodes of vaso-occlusive crisis (VOC) in
the past year

- Have a body weight =19 kilograms (kg) and are =2 and <18 years of age, inclusive at
the time of screening

- If participants are =2 and =16 years of age, must have had a transcranial Doppler
within the last year

Exclusion Criteria:

- History of: transient ischemic attack (TIA)/ ischemic or hemorrhagic stroke, severe
head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous
malformation, or aneurysm

- History of abnormal or conditional [velocity in middle or anterior cerebral, or
internal carotid artery =170 centimeter per second (cm/sec)] transcranial Doppler
within the last year

- History of, or are undergoing treatment with, chronic red blood cell (RBC) transfusion
therapy

- Are at an increased risk for bleeding complications

- Are receiving chronic treatment with nonsteroidal anti-inflammatory drug (NSAID)s and
cannot be switched to another analgesic



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sickle Cell Disease

Intervention(s)

Drug: Prasugrel

Drug: Placebo

Primary Outcome(s)

Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC) [Time Frame: Randomization through 24 Months]

Secondary Outcome(s)

Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions) [Time Frame: Randomization through 24 Months]

Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome) [Time Frame: Randomization through 24 Months]

Number of Days Hospitalized for VOC [Time Frame: Randomization through 24 Months]

Time From Randomization to First and Second VOC [Time Frame: Randomization to First VOC and Second VOC respectively (up to 24 Months)]

Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis) [Time Frame: Randomization through 24 Months]

Quarterly Rate of School Absence Due to Sickle Cell Pain [Time Frame: Randomization through 9 Months]

Monthly Mean in Faces Pain Scale-Revised Score [Time Frame: Randomization through 9 Months]

Monthly Rate of Days of Analgesic Use [Time Frame: Randomization through 9 Months]

Monthly Rate of Days With Pain [Time Frame: Randomization through 9 Months]

Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations) [Time Frame: Randomization through 24 Months]

Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention [Time Frame: First Dose through 24 Months]

Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke [Time Frame: Randomization through 24 Months]

Secondary ID(s)

2012-003837-41

H7T-MC-TADO

13038

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Daiichi Sankyo, Inc.

Results

• Results available: Yes
• Date Posted: 27/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01794000