Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease, Stroke

In brief

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.

Key facts

Study ID

NCT01389024

Run by

Johns Hopkins University

People needed

28

Starts

2012-08-16

Expected to finish

2022-05-24

Last updated by the study team

2024-07-10

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Mercy Children's Hospital — Kansas City, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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