Use of NovoSeven® in Active Variceal Bleeding

NCT ID: NCT00154492

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acquired Bleeding Disorder Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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activated recombinant human factor VII

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Variceal bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Olomouc, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Aarhus, , Denmark

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Novo Nordisk Investigational Site

Helsinki, , Finland

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Novo Nordisk Investigational Site

Angers, , France

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Novo Nordisk Investigational Site

Caen, , France

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Novo Nordisk Investigational Site

Clichy, , France

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Novo Nordisk Investigational Site

Grenoble, , France

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Novo Nordisk Investigational Site

Lille, , France

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Novo Nordisk Investigational Site

Limoges, , France

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Novo Nordisk Investigational Site

Marseille, , France

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Novo Nordisk Investigational Site

Nantes, , France

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Novo Nordisk Investigational Site

Nice, , France

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Novo Nordisk Investigational Site

Paris, , France

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Novo Nordisk Investigational Site

Paris, , France

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Novo Nordisk Investigational Site

Toulouse, , France

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Novo Nordisk Investigational Site

Villejuif, , France

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Novo Nordisk Investigational Site

Berlin, , Germany

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Novo Nordisk Investigational Site

Heidelberg, , Germany

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Novo Nordisk Investigational Site

Leipzig, , Germany

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Novo Nordisk Investigational Site

München, , Germany

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Novo Nordisk Investigational Site

Münster, , Germany

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Novo Nordisk Investigational Site

Ulm, , Germany

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Novo Nordisk Investigational Site

Shatin, , Hong Kong

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Novo Nordisk Investigational Site

Milan, , Italy

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Novo Nordisk Investigational Site

Napoli, , Italy

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Novo Nordisk Investigational Site

Palermo, , Italy

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Novo Nordisk Investigational Site

Katowice, , Poland

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Novo Nordisk Investigational Site

Krakow, , Poland

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Novo Nordisk Investigational Site

Warsaw, , Poland

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Novo Nordisk Investigational Site

Badalona, , Spain

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Novo Nordisk Investigational Site

Barcelona, , Spain

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Novo Nordisk Investigational Site

Barcelona, , Spain

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Novo Nordisk Investigational Site

Barcelona, , Spain

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Novo Nordisk Investigational Site

Córdoba, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

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Novo Nordisk Investigational Site

Majadahonda, , Spain

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Novo Nordisk Investigational Site

Taipei, , Taiwan

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Novo Nordisk Investigational Site

Leeds, , United Kingdom

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Novo Nordisk Investigational Site

London, , United Kingdom

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Novo Nordisk Investigational Site

Oxford, , United Kingdom

Site Status

Countries

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Austria Czechia Denmark Finland France Germany Hong Kong Italy Poland Spain Taiwan United Kingdom

References

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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.

Reference Type RESULT
PMID: 18580208 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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F7LIVER-1533

Identifier Type: -

Identifier Source: org_study_id

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