A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 主要终点
- DIC score
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 Japanese Association for Acute Medicine-defined DIC criteria.
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
- •Japanese Association for Acute Medicine-defined DIC criteria score >= 4
- •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
干预措施: KW-3357 (Drug)
结局指标
主要结局
DIC score
时间窗: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Based on the Japanese Association for Acute Medicine-defined DIC criteria
Mortality
时间窗: 28 days
Safety
时间窗: up to 6 days (or discontinuation)
Number of patients with adverse events
Organ symptoms
时间窗: Screening, 4, 6 days (or discontinuation)
Sepsis related organ failure assessment score
Severity
时间窗: Screening, 4, 6 days (or discontinuation)
The Acute Physiology and Chronic Health Evaluation II score
Plasma antithrombin activity
时间窗: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
DIC resolution
时间窗: 6 days (or discontinuation)
Japanese Association for Acute Medicine-defined DIC criteria score \< 4
次要结局
未报告次要终点