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This study examined the drug Hydroxyurea for treating beta-thalassemia (Cooley's anemia). Male and female patients older than 15 years with beta-thalassemia intermedia who met certain blood-value requirements could take part. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Beta-Thalassemia Intermedia patients. Steady-state Hb values greater than 6.5gm/dl (unrelated to transfusion) Males and females. Patients greater than 15 years of age. Patients who are transfusion-requiring but not dependent will be offered the opportunity to enroll. Stable renal and hepatic function Willingness to use appropriate birth control measures. Ability to give informed consent. No beta-thalassemia major. No blood transfusion requirement greater than 1 unit every 2 months over the last 12 months. No patients with WBC less than 4000/micrograms. No one with a platelet count less than 150,000/micrograms. No evidence of active viral infective, including viral hepatitis. No abnormal liver function test (ALT or AST greater than 2.5 x normal). No abnormal renal function test (creatinine greater 1.5 mg/dl). No HIV positive blood test.