Acquired Bleeding DisorderPhase 2NCT00266006

Factor VIIa in Acute Intracerebral Haemorrhage

A Phase 2 study testing eptacog alfa (activated) in people with Acquired Bleeding Disorder and Intracerebral Haemorrhage, run by Novo Nordisk A/S at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Acquired Bleeding Disorder, Intracerebral Haemorrhage
What is being tested?: eptacog alfa (activated)
How many people: 90 participants
Where: 1 siteJapan
Study dates: Jan 2006to Apr 2007
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Spontaneous ICH

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Novo Nordisk Investigational Site
Tokyo, 1000005

Other trials in Japan

About this study

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

Conditions: Acquired Bleeding Disorder, Intracerebral Haemorrhage
Being tested: eptacog alfa (activated)
Medical subject headings: Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eptacog alfa (activated)Drug
Also called activated recombinant human factor VII

What is being measured

The primary outcome is the main question the study is designed to answer.

The Occurrence of thromboembolic serious adverse event
Measured: Until 90 days

Secondary outcomes (2)

Reducing disability and improving clinical outcome
Reducing haematoma growth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Apr 2007

First posted15 Dec 2005 (estimated)
Study startJan 2006
Primary completionApr 2007
Study completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acquired Bleeding DisorderStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00266006
Sponsor's protocol ID: F7ICH-1602
Other IDs: JapicCTI-050194
Status last verified: Nov 2016
First submitted: 14 Dec 2005
Last updated: 18 Nov 2016
Results posted: No
Data monitoring committee: No

Publications

Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
PubMed 37870112

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acquired Bleeding Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.
ClinicalTrials.gov ID: NCT00266006
Acronym / sponsor ID: F7ICH-1602
Conditions: Acquired Bleeding Disorder, Intracerebral Haemorrhage
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Apr 2007 (actual)
Study completion: Apr 2007 (actual)
First posted: 15 Dec 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Spontaneous ICH

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
eptacog alfa (activated)Also: activated recombinant human factor VII	Drug	–

Primary outcome

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

2 secondary outcomes

Reducing disability and improving clinical outcome
Reducing haematoma growth

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
Derived from this study: PubMed 37870112Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Acquired Bleeding Disorder

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RecruitingObservational study
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Enrolling by invitationObservational study
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing eptacog alfa (activated) in people with Acquired Bleeding Disorder and Intracerebral Haemorrhage, run by Novo Nordisk A/S at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Occurrence of thromboembolic serious adverse event (time frame: Until 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00266006, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.