Use of NovoSeven® in Active Variceal Bleeding

January 12, 2017 updated by: Novo Nordisk A/S

Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, A 1090
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Olomouc, Czech Republic, 77520
        • Novo Nordisk Investigational Site
      • Prague 4, Czech Republic, 140 21
        • Novo Nordisk Investigational Site
      • Praha 2, Czech Republic, 12821
        • Novo Nordisk Investigational Site
  • Denmark
      • Århus, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00029 HUS
        • Novo Nordisk Investigational Site
  • France
      • 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
      • LIMOGES cedex, France, 87042
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • 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, 75013
        • Novo Nordisk Investigational Site
      • Paris, France, 75012
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31059
        • Novo Nordisk Investigational Site
      • Villejuif, France, 94804
        • Novo Nordisk Investigational Site
  • Germany
      • 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
        • Novo Nordisk Investigational Site
  • Hong Kong
      • Shatin, Hong Kong, 32
        • Novo Nordisk Investigational Site
  • Italy
      • Milano, Italy, 20162
        • Novo Nordisk Investigational Site
      • Napoli, Italy, 80131
        • Novo Nordisk Investigational Site
      • Palermo, Italy, 30146
        • Novo Nordisk Investigational Site
  • Poland
      • Katowice, Poland, 40-752
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-826
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-097
        • Novo Nordisk Investigational Site
  • Spain
      • Badalona, Spain, 08916
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08036
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08003
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08025
        • Novo Nordisk Investigational Site
      • Córdoba, Spain, 14004
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28034
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28007
        • Novo Nordisk Investigational Site
      • Majadahonda, Spain, 28222
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taipei, Taiwan, 112
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Novo Nordisk Investigational Site
      • London, United Kingdom, WC1 6HX
        • Novo Nordisk Investigational Site
      • Oxford, United Kingdom, OX3 9DU
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Variceal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment failure
Time Frame: Within 5 days after first trial product administration
Within 5 days after first trial product administration

Secondary Outcome Measures

Outcome Measure
Mortality
Rebleeding
Control of acute bleeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7LIVER-1533

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cirrhosis

Clinical Trials on activated recombinant human factor VII

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe