临床试验/NCT01563445

NCT01563445已完成2 期

Multi-center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) for Preventing Early Hematoma Growth in Acute Intracerebral Hemorrhage (ICH)

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2001年11月最近更新: 2017年1月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 40
试验地点: 1
主要终点: Occurrence of a treatment-related serious adverse event (SAE)

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研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).

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

•Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
•Signed informed consent form, or an exception from standard informed consent requirements

排除标准

•Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT
•Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, AVM (Arteriovenous Malformation) or severe trauma
•Surgical haematoma evacuation planned or performed within 24 hours of onset

研究组 & 干预措施

activated recombinant human factor VII

Experimental

干预措施: activated recombinant human factor VII (Drug)

Placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Occurrence of a treatment-related serious adverse event (SAE)

次要结局

Occurrence of adverse events
Change in ICH volume as measured by CT head scans

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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