Exploratory Efficacy and Safety, Pharmacokinetics and Dose Finding Study of ATryn® (Antithrombin Alfa) in Patients With Disseminated Intravascular Coagulation Associated With Severe Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 25
- 主要终点
- Patients Alive on Day 28, Having Had an Improvement in the DIC Score (Overt or Non-overt) by at Least 2 Points Between Baseline and Day 6 and Having Had no Worsening of the SOFA Score Between Baseline and Day 6.
研究概览
简要总结
The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent has been obtained from the patient or his/her legally acceptable representative
- •Severe sepsis
- •Disseminated intravascular coagulation
排除标准
- 未提供
研究组 & 干预措施
AT-150
Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%
干预措施: Antithrombin alfa (INN name) (Drug)
AT-250
Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%
干预措施: Antithrombin alfa (INN name) (Drug)
Control
The best standard treatment for the underlying condition only
干预措施: Control (Standard treatment) (Drug)
结局指标
主要结局
Patients Alive on Day 28, Having Had an Improvement in the DIC Score (Overt or Non-overt) by at Least 2 Points Between Baseline and Day 6 and Having Had no Worsening of the SOFA Score Between Baseline and Day 6.
时间窗: Day 28
Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome. Sepsis-related Organ Failure Assessment (SOFA) is a composite score of scores for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 to 4 with a higher score given for worse organ function. The scores are then added together to give a total range from 0 to 24 with a higher score representing a worse outcome.
次要结局
- Days Alive and Out of Hospital Day 28(Baseline to Day 28)
- Days Alive and Free of Inotrope/Vasopressor Support Day 28(Baseline to Day 28)
- Days Alive and Off Ventilator Day 28(Baseline to Day 28)
- Days Alive and Free of Need for Renal Replacement Therapy Day 28(Baseline to Day 28)
- Change From Baseline to Day 6 in Inflammation Marker IL-6(Baseline to Day 6)
- Change From Baseline to Day 6 in Inflammation Marker Procalcitonin(Baseline to Day 6)
- Mortality at Day 28(Day 28)
- Mortality at Day 90(Day 90)
- Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6(Baseline to Day 6)
- Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6(Baseline to Day 6)
- Days Alive and Out of ICU Day 28(Baseline to Day 28)