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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Primary Purpose

Acquired Bleeding Disorder, Intracerebral Haemorrhage

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
activated recombinant human factor VII
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Bleeding Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Reducing haematoma growth

Secondary Outcome Measures

Reducing disability and improving clinical outcome

Full Information

First Posted
January 24, 2007
Last Updated
January 17, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00426803
Brief Title
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Intracerebral Haemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Primary Outcome Measure Information:
Title
Reducing haematoma growth
Secondary Outcome Measure Information:
Title
Reducing disability and improving clinical outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom Exclusion Criteria: Patients with secondary ICH Pre-existing disability Haemophilia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
ZIP/Postal Code
VIC 3052
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Calgary
ZIP/Postal Code
AB T2N 2T9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00014
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Leipzig
ZIP/Postal Code
SN04103
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
308443
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE2 4HH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15728810
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. 2005 Feb 24;352(8):777-85. doi: 10.1056/NEJMoa042991.
Results Reference
result
PubMed Identifier
16636233
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 hemorrhage. Neurology. 2006 Apr 25;66(8):1175-81. doi: 10.1212/01.wnl.0000208408.98482.99.
Results Reference
result
PubMed Identifier
17038942
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 with recombinant activated factor VII. Neurosurgery. 2006 Oct;59(4):767-73; discussion 773-4. doi: 10.1227/01.NEU.0000232837.34992.32.
Results Reference
result
PubMed Identifier
16552014
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.
Results Reference
result
PubMed Identifier
17290026
Citation
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 Mar;38(3):1072-5. doi: 10.1161/01.STR.0000258078.35316.30. Epub 2007 Feb 8.
Results Reference
result
PubMed Identifier
17630481
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. doi: 10.1159/000104481. Epub 2007 Jun 28.
Results Reference
result
PubMed Identifier
18580208
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

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