NCT01384396已完成3 期
A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by the Diagnostic Criteria for DIC Established by the Japanese Ministry of Health and Welfare
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Safety
研究概览
简要总结
To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed or suspected as DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
- •Antithrombin activity <= 70%
- •Written informed consent from patient or guardian
排除标准
- •Anamnesis or complication of serious drug allergy
- •Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
- •Pregnant, nursing, or possibly pregnant woman
- •Possibility for the promotion of bleeding by concomitant use of heparin
研究组 & 干预措施
KW-3357
Experimental
干预措施: KW-3357 (Drug)
结局指标
主要结局
Safety
时间窗: up to 6 days (or discontinuation)
Number of patients with adverse events
DIC resolution
时间窗: 6 days (or discontinuation)
Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
次要结局
- DIC score(Screening, 2, 3, 4, 5, 6 days (or discontinuation))
- Plasma antithrombin activity(Screening, 2, 3, 4, 5, 6 days (or discontinuation))
- Mortality(28 days)
研究者
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