NCT01598831已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.
Asahi Kasei Pharma America Corporation131 个研究点 分布在 11 个国家目标入组 816 人开始时间: 2012年10月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 816
- 试验地点
- 131
- 主要终点
- Number of Participants With 28-Day All-cause Mortality
研究概览
简要总结
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
详细描述
Study is to evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, RR)
- •Clinical objective evidence of bacterial infection and a known site of infection.
- •Cardiovascular dysfunction or Respiratory Failure due to sepsis.
- •Coagulopathy characterized by an INR >1.40 without other known causes.
排除标准
- •Subject or Authorized Representative is unable to provide informed consent.
- •Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study.
- •Subject is of childbearing potential and does not have a negative pregnancy test.
- •Subject is < 18 years of age.
- •Subject has a known allergy to ART-123 or any components of the drug product.
- •Subject is unwilling to allow transfusion of blood or blood products.
- •Subject has an advance directive to withhold life-sustaining treatment.
- •Subject has had previous treatment with ART-
- •Body weight ≥ 175 kg.
- •Platelets < 30,000/ mm3 for any reason, PT prolongation or thrombocytopenia that is not due to sepsis.
- •Any surgery that is potentially hemorrhagic (e.g. intra-thoracic, intra-abdominal or non-traumatic orthopedic surgery of the femur or pelvis) that is completed within 12 hours prior to first dose of study drug, or ongoing impairment of hemostasis as a result of one of these procedures
- •History of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to consent.
- •Cerebral Vascular Accident (CVA) within 3 months prior to consent.
- •Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system.
- •History of congenital bleeding diathesesor anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia).
- •Significant gastrointestinal bleeding within 6 weeks prior to consent.
- •Subject is diagnosed with a known medical condition associated with a hypercoagulable state.
- •Child-Pugh score of 10-15 (Class C)
- •Portosystemic hypertension or known history of bleeding esophageal varices.
- •History of solid organ, allogeneic bone marrow, or stem cell transplantation within the 6 months prior to consent.
- •Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or gram stain consistent with bacterial infection.
- •Subjects with renal dysfunction defined as (a) Chronic renal failure requiring renal replacement therapy (RRT), or (b) Acute renal failure with onset of oliguria (urine output < 0.3 ml/kg/hr) > 48 hours prior to first dose of study drug whether receiving RRT or not
- •Use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 72 hours prior to first does of study drug.
- •Life expectancy < 90 days.
- •Current use of any chemotherapy agent likely to cause myeloablation (severe or complete depletion of bone marrow).
- •Participation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization.
- •Confirmed or suspected endocarditis
研究组 & 干预措施
ART-123
Active Comparator
干预措施: ART-123 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With 28-Day All-cause Mortality
时间窗: 28 days
28-Day All-cause Mortality
Number of Participants With On-Treatment Serious Major Bleeding Events
时间窗: Through Study Day 28
On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.)
次要结局
- Follow up All-cause Mortality at 3 Months(3 months)
- Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction(28 days)
- Number of Participants With Anti-drug Antibodies(18 months)
研究者
研究点 (131)
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