NCT00426803

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2002

Geographic Reach
14 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

January 24, 2007

Last Update Submit

January 17, 2017

Conditions

Acquired Bleeding DisorderIntracerebral Haemorrhage

Outcome Measures

Primary Outcomes (1)

  • Reducing haematoma growth

Secondary Outcomes (1)

  • Reducing disability and improving clinical outcome

Interventions

activated recombinant human factor VIIDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Novo Nordisk Investigational Site

Melbourne, VIC 3052, Australia

Location

Novo Nordisk Investigational Site

Graz, A-8036, Austria

Location

Novo Nordisk Investigational Site

Antwerp, 2020, Belgium

Location

Novo Nordisk Investigational Site

Calgary, AB T2N 2T9, Canada

Location

Novo Nordisk Investigational Site

Aarhus, 8000, Denmark

Location

Novo Nordisk Investigational Site

Helsinki, 00014, Finland

Location

Novo Nordisk Investigational Site

Leipzig, SN04103, Germany

Location

Novo Nordisk Investigational Site

Perugia, 06126, Italy

Location

Novo Nordisk Investigational Site

Amsterdam, 1105, Netherlands

Location

Novo Nordisk Investigational Site

Bergen, 5021, Norway

Location

Novo Nordisk Investigational Site

Singapore, 308443, Singapore

Location

Novo Nordisk Investigational Site

Madrid, 28040, Spain

Location

Novo Nordisk Investigational Site

Stockholm, 171 76, Sweden

Location

Novo Nordisk Investigational Site

Lausanne, 1011, Switzerland

Location

Novo Nordisk Investigational Site

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

Related Publications (8)

  • 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.

    PMID: 15728810RESULT

  • 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.

    PMID: 16636233RESULT

  • 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.

    PMID: 17038942RESULT

  • 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.

    PMID: 16552014RESULT

  • 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.

    PMID: 17290026RESULT

  • 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.

    PMID: 17630481RESULT

  • 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.

    PMID: 18580208RESULT

  • 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.

    PMID: 37870112DERIVED

Related Links

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2007

First Posted

January 25, 2007

Study Start

August 1, 2002

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

FI(1)NO(1)AU(1)BE(1)ES(1)SG(1)DE(1)SE(1)GB(1)DK(1)NL(1)IT(1)CA(1)CH(1)