Acquired Bleeding DisorderPhase 3FASTNCT00127283

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

A Phase 3 study testing eptacog alfa (activated) in people with Acquired Bleeding Disorder and Intracerebral Haemorrhage, run by Novo Nordisk A/S at 167 sites in 23 countries.

Completed

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

Official record

Search all trials

Trial summary

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America. The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acquired Bleeding Disorder, Intracerebral Haemorrhage
What is being tested?: eptacog alfa (activated)
How many people: 829 participants
Where: 167 sitesin 23 countries
Study dates: May 2005to Jan 2007
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Who cannot join

Patients with secondary ICH
Pre-existing disability
Haemophilia

Trial locations and contacts

167 sites in 23 countries.

Country

City, postcode or hospital

167 sites in 23 countries

United States77 sites

Novo Nordisk Investigational Site
Allentown, Pennsylvania, 18103-6208
Novo Nordisk Investigational Site
Atlanta, Georgia, 30320
Novo Nordisk Investigational Site
Augusta, Georgia, 30912-3260
Novo Nordisk Investigational Site
Baltimore, Maryland, 21287
Novo Nordisk Investigational Site
Birmingham, Alabama, 35209
Novo Nordisk Investigational Site
Blackwater, Mississippi, 39216
Novo Nordisk Investigational Site
Boston, Massachusetts, 02118
Novo Nordisk Investigational Site
Boston, Massachusetts, 02144
Novo Nordisk Investigational Site
Boston, Massachusetts, 02215
Novo Nordisk Investigational Site
Buffalo, New York, 14215
Novo Nordisk Investigational Site
Burlington, Vermont, 05401
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7025
Novo Nordisk Investigational Site
Charleston, South Carolina, 29425
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28232-2861
Novo Nordisk Investigational Site
Charlottesville, Virginia, 22908
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37403
Novo Nordisk Investigational Site
Cherry Hill, New Jersey, 08034
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, 60612
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45267
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8897
Novo Nordisk Investigational Site
Decatur, Georgia, 33033
Novo Nordisk Investigational Site
Denver, Colorado, 80204
Novo Nordisk Investigational Site
Denver, Colorado, 80262
Novo Nordisk Investigational Site
Detroit, Michigan, 48201
Novo Nordisk Investigational Site
Durham, North Carolina, 27705
Novo Nordisk Investigational Site
Englewood, Colorado, 80113
Novo Nordisk Investigational Site
Fort Smith, Arkansas, 72901
Novo Nordisk Investigational Site
Fort Wayne, Indiana, 46805
Novo Nordisk Investigational Site
Golden Valley, Minnesota, 55422
Novo Nordisk Investigational Site
Hackensack, New Jersey, 07465
Novo Nordisk Investigational Site
Hartford, Connecticut, 06102
Novo Nordisk Investigational Site
Hashville, Tennessee, 37232
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96813
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46260
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Jacksonville, Florida, 32209
Novo Nordisk Investigational Site
Kansas City, Missouri, 64111
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89109
Novo Nordisk Investigational Site
Lebanon, New Hampshire, 03756-0001
Novo Nordisk Investigational Site
Lexington, Kentucky, 40536
Novo Nordisk Investigational Site
Los Angeles, California, 90024
Novo Nordisk Investigational Site
Louisville, Kentucky, 40202
Novo Nordisk Investigational Site
Madison, Wisconsin, 53792-3236
Novo Nordisk Investigational Site
Maywood, Illinois, 60153
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Memphis, Tennessee, 38163
Novo Nordisk Investigational Site
Mobile, Alabama, 36617
Novo Nordisk Investigational Site
Nashville, Tennessee, 37205
Novo Nordisk Investigational Site
New York, New York, 10032
Novo Nordisk Investigational Site
Oceanside, California, 92056
Novo Nordisk Investigational Site
Orange, California, 92868-4280
Novo Nordisk Investigational Site
Peoria, Illinois, 61637
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Phoenix, Arizona, 85013
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15212-4746
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15213-2546
Novo Nordisk Investigational Site
Portland, Oregon, 97225
Novo Nordisk Investigational Site
Portland, Oregon, 97239
Novo Nordisk Investigational Site
Ridgewood, New Jersey, 07450
Novo Nordisk Investigational Site
Sacramento, California, 95816
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Diego, California, 92103
Novo Nordisk Investigational Site
San Francisco, California, 94110-3594
Novo Nordisk Investigational Site
San Francisco, California, 94143-0780
Novo Nordisk Investigational Site
Seattle, Washington, 98102
Novo Nordisk Investigational Site
St Louis, Missouri, 63110-1010
Novo Nordisk Investigational Site
St Louis, Missouri, 63110
Novo Nordisk Investigational Site
Stanford, California, 94305
Novo Nordisk Investigational Site
Stony Brook, New York, 11794-8121
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308
Novo Nordisk Investigational Site
Tampa, Florida, 33606
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, 20010
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada15 sites

Novo Nordisk Investigational Site
Calgary, T2N 2T9
Novo Nordisk Investigational Site
Edmonton, Alberta, T6G 2B7
Novo Nordisk Investigational Site
Greenfield Park, J4V 2H1
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 3A7
Novo Nordisk Investigational Site
London, N6A 5A5
Novo Nordisk Investigational Site
Mississauga, L5B 1B8
Novo Nordisk Investigational Site
Montreal, H2L 4M1
Novo Nordisk Investigational Site
Montreal, H3A 2B4
Novo Nordisk Investigational Site
Ottawa, KIH 8L6
Novo Nordisk Investigational Site
Québec, G1J 1Z4
Novo Nordisk Investigational Site
Saint John, E2L 4L2
Novo Nordisk Investigational Site
Saskatoon, S7N 0W8
Novo Nordisk Investigational Site
Thunder Bay, P7B 6V4
Novo Nordisk Investigational Site
Toronto, M4N 3M5
Novo Nordisk Investigational Site
Vancouver, V5Z 3J5

Other trials in Canada

Germany9 sites

Novo Nordisk Investigational Site
Berlin, 13353
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Essen, 45147
Novo Nordisk Investigational Site
Heidelberg, 69120
Novo Nordisk Investigational Site
Leipzig, 04103
Novo Nordisk Investigational Site
Mannheim, 68167
Novo Nordisk Investigational Site
Minden, 32427
Novo Nordisk Investigational Site
München, 81545
Novo Nordisk Investigational Site
Münster, 48149

Other trials in Germany

Netherlands6 sites

Novo Nordisk Investigational Site
Amsterdam, 1066 EC
Novo Nordisk Investigational Site
Amsterdam, 1105 AZ
Novo Nordisk Investigational Site
Eindhoven, 5623 EJ
Novo Nordisk Investigational Site
Heerlen, 6419 PC
Novo Nordisk Investigational Site
Rotterdam, 3015 GD
Novo Nordisk Investigational Site
Utrecht, 3584 CX

Other trials in Netherlands

Sweden6 sites

Novo Nordisk Investigational Site
Linköping, 581 85
Novo Nordisk Investigational Site
Malmö, 214 28
Novo Nordisk Investigational Site
Stockholm, 118 83
Novo Nordisk Investigational Site
Stockholm, 141 86
Novo Nordisk Investigational Site
Stockholm, 171 76
Novo Nordisk Investigational Site
Umeå, 901 85

Other trials in Sweden

France5 sites

Novo Nordisk Investigational Site
Bordeaux, 33076
Novo Nordisk Investigational Site
Paris, 75010
Novo Nordisk Investigational Site
Paris, 75013
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Toulouse, 31054

Other trials in France

Norway5 sites

Novo Nordisk Investigational Site
Bergen, 5021
Novo Nordisk Investigational Site
Kristiansand, 4604
Novo Nordisk Investigational Site
Nordbyhagen, 1474
Novo Nordisk Investigational Site
Stavanger, NO-4011
Novo Nordisk Investigational Site
Trondheim, NO-7030

Other trials in Norway

Spain5 sites

Novo Nordisk Investigational Site
Badalona, 08916
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Barcelona, 08036
Novo Nordisk Investigational Site
Girona, 17007
Novo Nordisk Investigational Site
Madrid, 28040

Other trials in Spain

Australia4 sites

Novo Nordisk Investigational Site
Camperdown, 2050
Novo Nordisk Investigational Site
Gosford, 2250
Novo Nordisk Investigational Site
Heidelberg Heights, 3081
Novo Nordisk Investigational Site
Parkville, Victoria, 3052

Other trials in Australia

Belgium4 sites

Novo Nordisk Investigational Site
Antwerp, 2020
Novo Nordisk Investigational Site
Bruges, 8000
Novo Nordisk Investigational Site
Brussels, 1070
Novo Nordisk Investigational Site
Brussels, 1200

Other trials in Belgium

Denmark4 sites

Novo Nordisk Investigational Site
Aalborg, 9100
Novo Nordisk Investigational Site
Aarhus, 8000
Novo Nordisk Investigational Site
Copenhagen
Novo Nordisk Investigational Site
Glostrup Municipality, 2600

Other trials in Denmark

Finland4 sites

Novo Nordisk Investigational Site
Helsinki, FI-00029
Novo Nordisk Investigational Site
Kuopio, FI-70211
Novo Nordisk Investigational Site
Seinäjoki, FI-60220
Novo Nordisk Investigational Site
Turku, FI-20521

Other trials in Finland

Italy4 sites

Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Pavia, 27100
Novo Nordisk Investigational Site
Perugia, 06156
Novo Nordisk Investigational Site
Roma, 00185

Other trials in Italy

China3 sites

Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100050
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200001
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200040

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Taiwan3 sites

Novo Nordisk Investigational Site
Taipei, 100
Novo Nordisk Investigational Site
Taipei, 114
Novo Nordisk Investigational Site
Taoyuan, 333

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Austria2 sites

Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Innsbruck, 6020

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Brazil2 sites

Novo Nordisk Investigational Site
Sao Cristóvao, 20941-150
Novo Nordisk Investigational Site
Vila Clementino, 04039-032

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Israel2 sites

Novo Nordisk Investigational Site
Tel Aviv, 64239
Novo Nordisk Investigational Site
Tel HaShomer, 52621

Other trials in Israel

Singapore2 sites

Novo Nordisk Investigational Site
Singapore, 119074
Novo Nordisk Investigational Site
Singapore, 308443

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Thailand2 sites

Novo Nordisk Investigational Site
Bangkok, 10330
Novo Nordisk Investigational Site
Bangkok, 10400

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Croatia1 site

Novo Nordisk Investigational Site
Zagreb, 10000

Other trials in Croatia

Hong Kong1 site

Novo Nordisk Investigational Site
Hong Kong

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Switzerland1 site

Novo Nordisk Investigational Site
Lausanne, 1011

Other trials in Switzerland

About this study

Official title: Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.

The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

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

What is being measured

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

Reducing disability and improving clinical outcome
Measured: After 3 months

Secondary outcomes (2)

Reducing mortality
Reducing hematoma growth

Timeline

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

May 2005Jan 2007

First posted5 Aug 2005 (estimated)
Study startMay 2005
Primary completionJan 2007
Study completionJan 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 829 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00127283
Sponsor's protocol ID: F7ICH-1641
Other IDs: 2004-004202-24, 2004
Acronym: FAST
Status last verified: Jan 2017
First submitted: 3 Aug 2005
Last updated: 12 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
PubMed 18580208
Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.
PubMed 18480205
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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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage
ClinicalTrials.gov ID: NCT00127283
Acronym / sponsor ID: FAST / F7ICH-1641
Conditions: Acquired Bleeding Disorder, Intracerebral Haemorrhage
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 829 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Jan 2007 (actual)
Study completion: Jan 2007 (actual)
First posted: 5 Aug 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.

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.

Study design

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Key exclusion criteria (3 listed)

Patients with secondary ICH
Pre-existing disability
Haemophilia

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)	Drug	–

Primary outcome

Reducing disability and improving clinical outcome
Time frame: After 3 months

2 secondary outcomes

Reducing mortality
Reducing hematoma 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 12 Jan 2017.
Results publication: PubMed 18580208Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
Results publication: PubMed 18480205Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.
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.

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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

167 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing eptacog alfa (activated) in people with Acquired Bleeding Disorder and Intracerebral Haemorrhage, run by Novo Nordisk A/S at 167 sites in 23 countries.

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 3 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Canada, Germany, Netherlands, Sweden and 18 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Reducing disability and improving clinical outcome (time frame: After 3 months). 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 NCT00127283, which also lists 3 linked publications.

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 12 Jan 2017.