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NCT00006400 · ClinicalTrials.gov registry record · Phase 3
Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia
A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 3
- Development phase
- 193
- Enrollment target
NCT00006400: Completed Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00006400 is a Phase 3 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 193 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006400, a Phase 3 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 193 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
Primary Outcome
Primary Endpoint: Spleen function was assessed by uptake of 99mTc sulfur colloid on liver-spleen scan before initiation of treatment (baseline) and 2 years later (exit). The results of each of the two scans were categorized as normal, functional but abnormal, or not functional by a panel of nuclear medicine specialists blinded to treatment assignment. The proportion of patients whose paired scans demonstrated a decline in splenic function was compared in the hydroxyurea versus placebo groups. T
Interventions
- DRUG Placebo
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2000-08 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00006400 record still lists
NCT00006400 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00006400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006400 about?
NCT00006400 is a clinical study titled "Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia". The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
What is the current status of trial NCT00006400?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 193 participants. The study started on 2000-08. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00006400?
The interventions under investigation include: Placebo (DRUG), Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT00006400?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00006400's enrollment target sits among peer trials
193 1397th of 2000 higher than 603 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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