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Completed

NCT Number: NCT00266006

Factor VIIa in 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.

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Key information

Conditions

Acquired Bleeding Disorder Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracerebral Haemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spontaneous ICH

Exclusion criteria

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

Treatment and study plan

eptacog alfa (activated)

Drug

Other names: activated recombinant human factor VII

Primary outcomes

  1. The Occurrence of thromboembolic serious adverse event

    Time frame: Until 90 days

Secondary outcomes

  1. Reducing disability and improving clinical outcome

  2. Reducing haematoma growth

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 15, 2005
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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