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OpenTrials
Completed

NCT Number: NCT00154492

Use of NovoSeven® in Active Variceal Bleeding

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.

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Key information

Conditions

Acquired Bleeding Disorder Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Variceal bleeding

Treatment and study plan

activated recombinant human factor VII

Drug

Primary outcomes

  1. Treatment failure

    Time frame: Within 5 days after first trial product administration

Secondary outcomes

  1. Mortality

  2. Rebleeding

  3. Control of acute bleeding

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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