Factor VIIa in Acute Intracerebral Haemorrhage - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00266006

Purpose

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.

Condition	Intervention	Phase
Intracerebral Haemorrhage	Drug: activated recombinant human factor VII	Phase II

Drug Information available for: Eptacog alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

The Occurrence of thromboembolic serious adverse event [ Time Frame: Until 90 days ]

Secondary Outcome Measures:

Reducing disability and improving clinical outcome
Reducing haematoma growth

Estimated Enrollment:	90
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Spontaneous ICH

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266006

Locations

Japan

Morioka, Japan

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Morio Arai, MD, PhD

Novo Nordisk Pharma Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	F7ICH-1602, JAPIC: JapicCTI-050194
Study First Received:	December 14, 2005
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00266006
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Cerebral Hemorrhage
Vascular Diseases
Central Nervous System Diseases
Intracranial Hemorrhages

Brain Diseases
Hemorrhage
Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009