NCT01384903已完成3 期
An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection
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
- 221
- 主要终点
- DIC resolution
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Meet the ACCP/SCCM-defined sepsis criteria
- •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
研究组 & 干预措施
KW-3357
Experimental
干预措施: KW-3357 (Drug)
Plasma-derived antithrombin
Active Comparator
干预措施: Plasma-derived antithrombin (Drug)
结局指标
主要结局
DIC resolution
时间窗: 6 days (or discontinuation)
Japanese Association for Acute Medicine-defined DIC criteria score \< 4
次要结局
- Mortality(28 days)
- Plasma antithrombin activity(Screening, 2, 3, 4, 5, 6 days (or discontinuation))
- Severity(Screening, 4, 6 days (or discontinuation))
- DIC score(Screening, 2, 3, 4, 5, 6 days (or discontinuation))
- Organ symptoms(Screening, 4, 6 days (or discontinuation))
- Number of patients with adverse events(up to 6 days (or discontinuation))
研究者
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