Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease
Status:
Active, not recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
This is a pilot study of hydroxyurea versus placebo to reduce central nervous system
complications (abnormally fast blood flow to the brain, silent cerebral infarct or stroke) in
young children with sickle cell disease. The investigators plan to identify children 12 to 48
months old without central nervous system complications and randomly assign 20 to treatment
with hydroxyurea and 20 to treatment with placebo for 36 months. Neither the study doctors
nor the participants will know which treatment they are receiving.
Phase:
Phase 2
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Children's Hospital of Philadelphia Children's Mercy Hospital Kansas City Columbia University Medical University of South Carolina Mercy Children's Hospital National Center for Research Resources (NCRR) RTI International Sinai Hospital of Baltimore University of Alabama at Birmingham Vanderbilt University School of Medicine Washington University School of Medicine