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Clinical trialNCT01389024CompletedPhase 2Interventional

Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease

SponsorJohns Hopkins UniversityEnrollment28Sickle Cell DiseaseStroke
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Hydroxyurea →Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Aug 2012
Primary completion
24 May 2022
Completion
24 May 2022
Last update posted
10 Jul 2024
Registered enrollment
28
Registry id
NCT01389024
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.