Sickle Cell Anemia
Conditions
Keywords
genetic diseases and dysmorphic syndromes, hematologic disorders, rare disease, sickle cell anemia
Brief summary
OBJECTIVES: I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months. Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks. Completion date provided represents the completion date of the grant per OOPD records
Interventions
DRUGclotrimazole
DRUGhydroxyurea
Sponsors
University of North Carolina
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis Received hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day --Prior/Concurrent Therapy-- Chemotherapy: * No other concurrent antisickling agent Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole --Patient Characteristics-- Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL Hepatic: AST/ALT no greater than 100 units/L Renal: Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No prior adverse reaction to hydroxyurea or clotrimazole * No recent or progressive neurologic dysfunction
Countries
United States
Outcome results
None listed