NCT00107913Unknown2 期
Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Hematology and Oncology Specialists2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2001年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- the primary outcome would be a platelet response, with a return of platelet count to normal
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).
详细描述
Eligible patients will receive Doxil 20 mg/m2 IV over 1 hour every 2 weeks. Treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes.
- •Failure to respond to initial treatment with steroids, IV immune globulin, splenectomy and post splenectomy steroids.
- •Platelet count of 30,000 or less.
- •Performance status score of 2 or less.
- •Adequate organ function: *bilirubin< 2; *AST < 3 times normal; *creatinine <
- •No prior treatment with anthracycline or chemically related drugs.
排除标准
- •Pregnant or lactating women.
- •Presence of a malignancy other than basal cell carcinoma of the skin.
结局指标
主要结局
the primary outcome would be a platelet response, with a return of platelet count to normal
次要结局
未报告次要终点
研究者
研究点 (2)
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