Sickle Cell Acute Chest Syndrome Treatment with Prasugrel – Phase III

A Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease

Protocol Description

The purpose of the study is to evaluate the efficacy and safety of the drug prasugrel for the reduction of acute chest syndrome, a severe form of vaso-occlusive crisis (VOC), in children, adolescents, and teens with sickle cell disease. The study will also investigate reduction in daily pain in children who have sickle cell disease.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting participants of both genders, ages of 2 through 17, who have sickle cell disease and who have experienced 2 or more sickle cell-related pain episodes within the past year.
Males: 2 to 17 years old
Females: 2 to 17 years old

Requirements

Following initial screening, participants will be placed into one of two study groups: one that takes the study drug and one that takes a placebo. The drug and placebo are in tablet form, taken orally each day, and most dosages will be taken at home. For participants older than 4, an electronic diary will be provided for recording daily pain, use of medications and any difficulties conducting normal activities. Periodic office visits will be required for examinations and blood samples.
Visits: 12
Duration: 9 months to 2 years

Status: Open for Enrollment

Source(s) of Support

Eli Lilly and Company

Primary Investigator

Debra Cohen, MD

Contact Information

For information about the study or enrollment, please contact:
Study Coordinator Angela Martino, BSN, RN
412-692-6467