临床试验/NCT00487656

NCT00487656已完成2 期

A Randomized, Double-Blind, Placebo-Controlled, Phase-2B Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular Coagulation

Artisan Pharma, Inc.0 个研究点目标入组 750 人开始时间: 2007年7月最近更新: 2011年5月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Artisan Pharma, Inc.
入组人数: 750
主要终点: 28-Day All-cause mortality

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.

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: Double (Participant, Investigator)

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

•Infection or suspected infection resulting in sepsis and DIC

排除标准

•Unable to provide informed consent, or lack of consent from an acceptable surrogate
•Subjects < 18 years of age
•Known conditions that could confound the diagnosis of DIC due to sepsis
•Known conditions that increase the risk of bleeding
•Known medical condition associated with a hypercoagulable state
•Known or suspected severe liver disease
•History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation
•Renal failure

研究组 & 干预措施

ART-123

Experimental

6 mg/ml ampule solution for injection

干预措施: ART-123 (Drug)

Placebo

Placebo Comparator

6 mg/mlampule of solution for injection

干预措施: placebo (Drug)

结局指标

主要结局

28-Day All-cause mortality

时间窗: 28 day

次要结局

未报告次要终点

研究者

发起方

Artisan Pharma, Inc.

申办方类型

Industry

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