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Use of NovoSeven® in Active Variceal Bleeding

Primary Purpose

Acquired Bleeding Disorder, Cirrhosis

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 focused on measuring Active variceal bleeding in patients with advanced cirrhosis

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Variceal bleeding

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
  • 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
  • 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

Treatment failure

Secondary Outcome Measures

Mortality
Rebleeding
Control of acute bleeding

Full Information

First Posted
September 9, 2005
Last Updated
January 12, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00154492
Brief Title
Use of NovoSeven® in Active Variceal Bleeding
Official Title
Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (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 and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Cirrhosis
Keywords
Active variceal bleeding in patients with advanced cirrhosis

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Primary Outcome Measure Information:
Title
Treatment failure
Time Frame
Within 5 days after first trial product administration
Secondary Outcome Measure Information:
Title
Mortality
Title
Rebleeding
Title
Control of acute bleeding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Variceal bleeding
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
Wien
ZIP/Postal Code
A 1090
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Prague 4
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
12821
Country
Czech Republic
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
00029 HUS
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
ANGERS cedex 09
ZIP/Postal Code
49033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Clichy
ZIP/Postal Code
92 188
Country
France
Facility Name
Novo Nordisk Investigational Site
City
GRENOBLE cedex
ZIP/Postal Code
38043
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LIMOGES cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MARSEILLE cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NANTES cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NICE cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
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
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Shatin
ZIP/Postal Code
32
Country
Hong Kong
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Palermo
ZIP/Postal Code
30146
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
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
08003
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
WC1 6HX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

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
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Use of NovoSeven® in Active Variceal Bleeding

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