Use of NovoSeven® in Active Variceal Bleeding

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154492

Enrollment

265

Registered

2005-09-12

Start date

2004-04-30

Completion date

2006-08-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Cirrhosis

Keywords

Active variceal bleeding in patients with advanced cirrhosis

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.

Interventions

DRUGactivated recombinant human factor VII

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Variceal bleeding

Design outcomes

Primary

Measure	Time frame
Treatment failure	Within 5 days after first trial product administration

Secondary

Measure	Time frame
Mortality	—
Rebleeding	—
Control of acute bleeding	—

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026