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Use of NovoSeven® in Active Variceal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00154492
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Acquired Bleeding Disorder Cirrhosis Drug: activated recombinant human factor VII Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis
Study Start Date : April 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: Within 5 days after first trial product administration ]

Secondary Outcome Measures :
  1. Mortality
  2. Rebleeding
  3. Control of acute bleeding


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Variceal bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154492


Locations
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Austria
Novo Nordisk Investigational Site
Wien, Austria, A 1090
Czech Republic
Novo Nordisk Investigational Site
Olomouc, Czech Republic, 77520
Novo Nordisk Investigational Site
Prague 4, Czech Republic, 140 21
Novo Nordisk Investigational Site
Praha 2, Czech Republic, 12821
Denmark
Novo Nordisk Investigational Site
Århus, Denmark, 8000
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00029 HUS
France
Novo Nordisk Investigational Site
ANGERS cedex 09, France, 49033
Novo Nordisk Investigational Site
Caen, France, 14033
Novo Nordisk Investigational Site
Clichy, France, 92 188
Novo Nordisk Investigational Site
GRENOBLE cedex, France, 38043
Novo Nordisk Investigational Site
Lille, France, 59037
Novo Nordisk Investigational Site
LIMOGES cedex, France, 87042
Novo Nordisk Investigational Site
MARSEILLE cedex 05, France, 13385
Novo Nordisk Investigational Site
NANTES cedex 1, France, 44093
Novo Nordisk Investigational Site
NICE cedex 3, France, 06202
Novo Nordisk Investigational Site
Paris, France, 75012
Novo Nordisk Investigational Site
Paris, France, 75013
Novo Nordisk Investigational Site
TOULOUSE cedex, France, 31059
Novo Nordisk Investigational Site
Villejuif, France, 94804
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Heidelberg, Germany, 69120
Novo Nordisk Investigational Site
Leipzig, Germany, 04103
Novo Nordisk Investigational Site
München, Germany, 81377
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Ulm, Germany, 89081
Hong Kong
Novo Nordisk Investigational Site
Shatin, Hong Kong, 32
Italy
Novo Nordisk Investigational Site
Milano, Italy, 20162
Novo Nordisk Investigational Site
Napoli, Italy, 80131
Novo Nordisk Investigational Site
Palermo, Italy, 30146
Poland
Novo Nordisk Investigational Site
Katowice, Poland, 40-752
Novo Nordisk Investigational Site
Krakow, Poland, 31-826
Novo Nordisk Investigational Site
Warszawa, Poland, 02-097
Spain
Novo Nordisk Investigational Site
Badalona, Spain, 08916
Novo Nordisk Investigational Site
Barcelona, Spain, 08003
Novo Nordisk Investigational Site
Barcelona, Spain, 08025
Novo Nordisk Investigational Site
Barcelona, Spain, 08036
Novo Nordisk Investigational Site
Córdoba, Spain, 14004
Novo Nordisk Investigational Site
Madrid, Spain, 28007
Novo Nordisk Investigational Site
Madrid, Spain, 28034
Novo Nordisk Investigational Site
Majadahonda, Spain, 28222
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan, 112
United Kingdom
Novo Nordisk Investigational Site
Leeds, United Kingdom, LS9 7TF
Novo Nordisk Investigational Site
London, United Kingdom, WC1 6HX
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00154492    
Other Study ID Numbers: F7LIVER-1533
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Keywords provided by Novo Nordisk A/S:
Active variceal bleeding in patients with advanced cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders