Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426803

Enrollment

400

Registered

2007-01-25

Start date

2002-08-31

Completion date

2004-06-30

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Intracerebral Haemorrhage

Brief summary

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.

Interventions

DRUGactivated recombinant human factor VII

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Reducing haematoma growth	—

Secondary

Measure	Time frame
Reducing disability and improving clinical outcome	—

Countries

Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Italy, Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026