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NCT00001197 · ClinicalTrials.gov registry record · Phase 2
Hydroxyurea for the Treatment of Patients With Sickle Cell Anemia
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00001197: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00001197 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001197, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
A total of fifty severely affected patients with homozygous sickle cell disease or other sickling disorders (e.g. B negative or B positive Thalassemia/Sickle) who are greater than 18 years of age will be eligible for treatment. Such patients must be able to tolerate an extensive period without blood transfusion and have relatively well preserved renal and hepatic function (creatinine less than 1.5 mg/dl and normal liver function test with exception of a mild elevation in transaminase). Evidence of severe sickle cell anemia will include recurrent pain crisis, chronic bone oain, evidence of aseptic necrosis with symptoms, and intractable leg ulcer, etc. On admission to the study, each patient will receive a complete history and physical examination. These data and standard laboratory evaluation, including a test for pregnancy if appropriate, will be adequate to ascertain whether any of the criteria for exclusion are present. Each patient must accept responsibility for for using an effective means of contraception. Patients who are found to be HIV positive will be excluded from the study....
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 1984-02-07 |
| Est. Completion | 2015-05-18 |
| Phase | Phase 2 |
What the finished NCT00001197 record still lists
NCT00001197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT00001197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001197 about?
NCT00001197 is a clinical study titled "Hydroxyurea for the Treatment of Patients With Sickle Cell Anemia". A total of fifty severely affected patients with homozygous sickle cell disease or other sickling disorders (e.g. B negative or B positive Thalassemia/Sickle) who are greater than 18 years of age will be eligible for treatment. Such patients must be able to tolerate an extensive period without blood...
What is the current status of trial NCT00001197?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 1984-02-07. Estimated completion is 2015-05-18.
What interventions are being tested in trial NCT00001197?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT00001197?
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 NCT00001197's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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