Factor VIIa in Acute Intracerebral Haemorrhage

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00266006

Enrollment

Registered

2005-12-15

Start date

2006-01-31

Completion date

2007-04-30

Last updated

2016-11-18

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 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.

Interventions

DRUGeptacog alfa (activated)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Spontaneous ICH

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The Occurrence of thromboembolic serious adverse event	Until 90 days

Secondary

Measure	Time frame
Reducing disability and improving clinical outcome	—
Reducing haematoma growth	—

Countries

Japan

Outcome results

None listed

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