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NCT00001958 · ClinicalTrials.gov registry record · Phase 2
Hydroxyurea to Treat Beta-Thalassemia (Cooley's Anemia)
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00001958 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 100 participants.
The verdict
NCT00001958, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This 12-month study will evaluate the safety and effectiveness of hydroxyurea in treating beta-thalassemia, a type of anemia caused by defective hemoglobin (the oxygen-carrying pigment in blood). Hemoglobin is composed of two protein chains-alpha globin chains and beta globin chains; patients with beta-thalassemia do not make beta globin. Patients often require frequent red blood cell transfusions. This leads to iron overload, which, in turn, requires iron chelation therapy (removal of iron from the blood). Some drugs, including hydroxyurea, can stimulate production of a third type of protein chain called gamma chains. In the womb, the fetus makes this type of protein instead of beta globin. It is not until after birth, when the fetus no longer produces gamma globin that the beta globin deficiency becomes apparent. Gamma chain synthesis improves hemoglobin and red blood cell production, correcting the anemia. This study will determine if and at what dose hydroxyurea treatment reduces patients' need for red blood cell transfusions and whether certain factors might predict which patients are likely benefit from this treatment. Patients 15 years and older with moderately severe beta-thalassemia may be eligible for this study. Participants will take hydroxyurea daily at a dose calculated according to the patient's body size. Blood will be drawn weekly to measure blood cell and platelet counts. The drug dosage may be increased after 12 weeks of treatment and again after 24 weeks if the white cell and platelet counts remain stable. Patients who respond dramatically to treatment may continue to receive hydroxyurea for up to 3 years.
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 1999-12 |
| Est. Completion | 2002-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001958
The ClinicalTrials.gov registry entry for NCT00001958 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT00001958 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001958 about?
NCT00001958 is a clinical study titled "Hydroxyurea to Treat Beta-Thalassemia (Cooley's Anemia)". This 12-month study will evaluate the safety and effectiveness of hydroxyurea in treating beta-thalassemia, a type of anemia caused by defective hemoglobin (the oxygen-carrying pigment in blood). Hemoglobin is composed of two protein chains-alpha globin chains and beta globin chains; patients with b...
What is the current status of trial NCT00001958?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 1999-12. Estimated completion is 2002-02.
What interventions are being tested in trial NCT00001958?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT00001958?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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