Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Acquired Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426803
• Other study ID #: F7ICH-1371
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2007
• Last updated: January 17, 2017
• Start date: August 2002
• Est. completion date: June 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with secondary ICH

• Pre-existing disability

• Haemophilia

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Cerebral Hemorrhage
• Hemorrhage
• Hemostatic Disorders
• Intracerebral Haemorrhage

Intervention

Drug:
• activated recombinant human factor VII

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Melbourne
Austria	Novo Nordisk Investigational Site	Graz
Belgium	Novo Nordisk Investigational Site	Antwerpen
Canada	Novo Nordisk Investigational Site	Calgary
Denmark	Novo Nordisk Investigational Site	Aarhus
Finland	Novo Nordisk Investigational Site	Helsinki
Germany	Novo Nordisk Investigational Site	Leipzig
Italy	Novo Nordisk Investigational Site	Perugia
Netherlands	Novo Nordisk Investigational Site	Amsterdam
Norway	Novo Nordisk Investigational Site	Bergen
Singapore	Novo Nordisk Investigational Site	Singapore
Spain	Novo Nordisk Investigational Site	Madrid
Sweden	Novo Nordisk Investigational Site	Stockholm
Switzerland	Novo Nordisk Investigational Site	Lausanne
United Kingdom	Novo Nordisk Investigational Site	Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

References & Publications (7)

Broderick JP, Diringer MN, Hill MD, Brun NC, Mayer SA, Steiner T, Skolnick BE, Davis SM; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators.. Determinants of intracerebral hemorrhage growth: an exploratory analysis. Stroke. 2007 — View Citation

Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, Begtrup K, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators.. Hematoma growth is a determinant of mortality and poor outcome after intracerebral he — View Citation

Diringer MN, Ferran JM, Broderick J, Davis S, Mayer SA, Steiner T, Brun NC, Skolnick BE, Christensen MC. Impact of recombinant activated factor VII on health-related quality of life after intracerebral hemorrhage. Cerebrovasc Dis. 2007;24(2-3):219-25. — View Citation

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. — View Citation

Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators.. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 200 — View Citation

Steiner T, Diringer MN, Schneider D, Mayer SA, Begtrup K, Broderick J, Skolnick BE, Davis SM. Dynamics of intraventricular hemorrhage in patients with spontaneous intracerebral hemorrhage: risk factors, clinical impact, and effect of hemostatic therapy wi — View Citation

Zimmerman RD, Maldjian JA, Brun NC, Horvath B, Skolnick BE. Radiologic estimation of hematoma volume in intracerebral hemorrhage trial by CT scan. AJNR Am J Neuroradiol. 2006 Mar;27(3):666-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing haematoma growth
Secondary	Reducing disability and improving clinical outcome

External Links

•   Clinical Trials at Novo Nordisk