Status:
TERMINATED
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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 d...
Detailed Description
The submission database was validated for data reported through the data cutoff date for the submission database lock (SDBL). The SDBL data cutoff was 17 July 2015 for all participants except for 2 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT01794000
Start Date
April 1 2013
End Date
December 1 2015
Last Update
September 25 2019
Active Locations (50)
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1
Children's Hospital of Oakland
Oakland, California, United States, 94609
2
Stanford Univ Medical Center
Palo Alto, California, United States, 94304
3
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
4
Howard University Hospital
Washington D.C., District of Columbia, United States, 20060