Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT00004492
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004492
Study Brief:
Protocol Section:
NCT00004492