Hydroxyurea for the Treatment of Patients With Sickle Cell Anemia
Status:
Completed
Trial end date:
2015-05-18
Target enrollment:
Participant gender:
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....