Factor VIIa in Acute Intracerebral Haemorrhage

Novo Nordisk A/S90 enrolled

Overview

This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acquired Bleeding Disorder Intracerebral Haemorrhage

Interventions

eptacog alfa (activated)DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Spontaneous ICH Exclusion Criteria: * Time of ICH onset \> 3 hours * Patients with secondary ICH * Pre-existing disability * Hemophilia

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

The Occurrence of thromboembolic serious adverse event

Time frame: Until 90 days

Secondary Outcomes

Reducing disability and improving clinical outcome

Reducing haematoma growth

Data from ClinicalTrials.gov

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