NCT00004492已完成1 期
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No prior adverse reaction to hydroxyurea or clotrimazole
- •No recent or progressive neurologic dysfunction
排除标准
- 未提供
研究者
研究点 (1)
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