CClinicalTrials.gg
CompletedNCT00266006Updated Nov 18, 2016

Factor VIIa in Acute Intracerebral Haemorrhage

A Phase 2 interventional study of eptacog alfa (activated) in Acquired Bleeding Disorder and Intracerebral Haemorrhage, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acquired Bleeding Disorder
  • Intracerebral Haemorrhage
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 90 is close to the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Spontaneous ICH

Exclusion criteria

Exclusion Criteria:

  • Time of ICH onset > 3 hours
  • Patients with secondary ICH
  • Pre-existing disability
  • Hemophilia
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Interventions

  • Drugeptacog alfa (activated)

    Also known as: activated recombinant human factor VII

06

What researchers measure

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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Tokyo, 1000005, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00266006
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 15, 2005
Start date
Jan 2006
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Nov 18, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion