Factor VIIa in Acute Intracerebral Haemorrhage

November 16, 2016 updated by: Novo Nordisk A/S

Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: eptacog alfa (activated)

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Tokyo, Japan, 1000005
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Spontaneous ICH

Exclusion Criteria:

Time of ICH onset > 3 hours
Patients with secondary ICH
Pre-existing disability
Hemophilia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Occurrence of thromboembolic serious adverse event Time Frame: Until 90 days	Until 90 days

Secondary Outcome Measures

Outcome Measure
Reducing disability and improving clinical outcome
Reducing haematoma growth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)