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NCT01389024 · ClinicalTrials.gov registry record · Phase 2
Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT01389024: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT01389024 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01389024, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
A composite of abnormally elevated cerebral blood flow velocity as measured by transcranial Doppler ultrasound, silent cerebral infarct, or stroke.
Interventions
- DRUG Placebo
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-08-16 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 2 |
What the finished NCT01389024 record still lists
NCT01389024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01389024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01389024 about?
NCT01389024 is a clinical study titled "Hydroxyurea to Prevent Brain Injury in Sickle Cell Disease". 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 ...
What is the current status of trial NCT01389024?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2012-08-16. Estimated completion is 2022-05-24.
What interventions are being tested in trial NCT01389024?
The interventions under investigation include: Placebo (DRUG), Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT01389024?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01389024's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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