临床试验/NCT00127283

NCT00127283已完成3 期

Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

Novo Nordisk A/S168 个研究点分布在 2 个国家目标入组 829 人开始时间: 2005年5月最近更新: 2017年1月12日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 829
试验地点: 168
主要终点: Reducing disability and improving clinical outcome

研究概览研究设计入排标准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 Asia, Europe, Middle East, North America, Oceania, and South America.

The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

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 intracranial hemorrhage (ICH) within 3 hours after first symptom

排除标准

•Patients with secondary ICH
•Pre-existing disability
•Haemophilia

结局指标

主要结局

Reducing disability and improving clinical outcome

时间窗: After 3 months

次要结局

Reducing mortality
Reducing hematoma growth

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (168)

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