NCT01561352已完成2 期
An Open Label Pilot Study to Test the Efficacy and Safety of Recombinant Factor VIIa (rFVIIa, NovoSeven®) in the Treatment of Refractory Hemorrhagic Cystitis Following High Dose Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the efficacy of activated recombinant human factor VII in the treatment of refractory haemorrhagic cystitis (HC) following chemotherapy.
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe haemorrhagic cystitis (HC)
排除标准
- •Patients with overt DIC (disseminated intravascular coagulation)
- •Patients with known active atherosclerotic disease, such as active coronary artery disease or recent stroke in the past 3 months
- •Central venous access device related thrombus in the last 3 months
- •Patients with allergy to activated recombinant human factor VII or any component of its preparation
研究组 & 干预措施
Factor VII
Experimental
干预措施: activated recombinant human factor VII (Drug)
结局指标
主要结局
Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color
Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit
Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content
次要结局
- Symptoms of venous or arterial thrombosis
研究者
研究点 (1)
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