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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

Primary Purpose

Acquired Bleeding Disorder, Intracerebral Haemorrhage

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
eptacog alfa (activated)
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 hemorrhage (ICH) within 3 hours after first symptom Exclusion Criteria: Patients with secondary ICH Pre-existing disability Haemophilia

Sites / Locations

  • Novo Nordisk Investigational Site
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Outcomes

Primary Outcome Measures

Reducing disability and improving clinical outcome

Secondary Outcome Measures

Reducing mortality
Reducing hematoma growth

Full Information

First Posted
August 3, 2005
Last Updated
January 11, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00127283
Brief Title
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
Acronym
FAST
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (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, 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.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
829 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Primary Outcome Measure Information:
Title
Reducing disability and improving clinical outcome
Time Frame
After 3 months
Secondary Outcome Measure Information:
Title
Reducing mortality
Title
Reducing hematoma growth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spontaneous intracranial hemorrhage (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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868-4280
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94110-3594
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0780
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30320
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3260
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
33033
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07465
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7025
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103-6208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4746
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2546
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8897
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98102
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-3236
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg Heights
ZIP/Postal Code
3081
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Sao Cristóvao
ZIP/Postal Code
20941-150
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Vila Clementino
ZIP/Postal Code
04039-032
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Calgary
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Greenfield Park
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mississauga
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Ottawa
ZIP/Postal Code
KIH 8L6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Saint John
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Saskatoon
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Thunder Bay
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Vancouver
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Copenhagen
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
FI-00029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
FI-70211
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Seinäjoki
ZIP/Postal Code
FI-60220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20521
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31054
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Minden
ZIP/Postal Code
32427
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
81545
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novo Nordisk Investigational Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1066 EC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kristiansand S
ZIP/Postal Code
4604
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Nordbyhagen
ZIP/Postal Code
1474
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
NO-4011
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Trondheim
ZIP/Postal Code
NO-7030
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
308443
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
214 28
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
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
PubMed Identifier
18480205
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

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