Use of NovoSeven® in Active Variceal Bleeding

Phase 2

Completed

• Conditions: Cirrhosis; Acquired Bleeding Disorder

• Registration Number: NCT00154492
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

• Variceal bleeding

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment failure	Within 5 days after first trial product administration

Secondary Outcome Measures

Name	Time	Method
Mortality
Rebleeding
Control of acute bleeding

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Oxford, United Kingdom