NCT01704001已完成4 期
A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Composite of Pharmacokinetics
研究概览
简要总结
To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.
To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Japanese Association for Acute Medicine-defined DIC criteria score >= 4
- •Written informed consent from patient or guardian
排除标准
- •Patients showing intracranial, pulmonary, gastrointestinal hemorrhage
- •Patients with a history of cerebrovascular disorders within the past 52 week
- •Patients with a history of hypersensitivity to the ingredients of ART-123 preparations
- •Pregnant women, nursing mothers or possibly pregnant women
研究组 & 干预措施
Renal impairment grade 1
Experimental
干预措施: ART-123 (Drug)
Renal impairment grade 0
Experimental
干预措施: ART-123 (Drug)
Renal impairment grade 2
Experimental
干预措施: ART-123 (Drug)
Renal impairment grade 3
Experimental
干预措施: ART-123 (Drug)
结局指标
主要结局
Composite of Pharmacokinetics
时间窗: pre-dose, 0,2,4,8,24 hours post-dose
Cmax, Area Under Curve, T1/2,CLtot,CLR
Incidence rate of hemorrhage related adverse events
时间窗: from the start of infusion to 8days after the cessation of infusion
次要结局
未报告次要终点
研究者
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