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Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII 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
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
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 ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
  • Signed informed consent form, or in countries where waiver of informed consent is allowed by IRB/IEC, a completed waiver form

Exclusion Criteria:

  • Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT
  • Patients with secondary ICH related to infarction, haemophilia or other coagulopathy, tumour, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
  • Surgical haematoma evacuation planned or performed within 24 hours of onset

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

activated recombinant human factor VII

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in ICH volume as measured by CT head scans

Secondary Outcome Measures

Occurrence of adverse events
Occurrence of serious adverse events

Full Information

First Posted
March 27, 2012
Last Updated
January 11, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01566786
Brief Title
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
Official Title
Randomised, Double-Blind, Placebo-Controlled, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy 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 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (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 Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).

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
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
activated recombinant human factor VII
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
Primary Outcome Measure Information:
Title
Change in ICH volume as measured by CT head scans
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Title
Occurrence of serious adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset Signed informed consent form, or in countries where waiver of informed consent is allowed by IRB/IEC, a completed waiver form Exclusion Criteria: Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT Patients with secondary ICH related to infarction, haemophilia or other coagulopathy, tumour, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma Surgical haematoma evacuation planned or performed within 24 hours of onset
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
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Copenhagen
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
60120
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
308443
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Taiwan
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Newcastle
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15569871
Citation
Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; Europe/AustralAsia NovoSeven ICH Trial Investigators. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke. 2005 Jan;36(1):74-9. doi: 10.1161/01.STR.0000149628.80251.b8. Epub 2004 Nov 29.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage

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