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Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage

Acquired Bleeding Disorder Clinical Trial

Official title:
Randomised, Double-Blind, Placebo-Controlled, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage

Clinical Trial Summary

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01566786
Study type Interventional
Source Novo Nordisk A/S
Contact
Status Completed
Phase Phase 2
Start date August 2001
Completion date October 2002
View Details
See also
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Terminated NCT00184548 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Phase 3
Completed NCT01563445 - Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage Phase 2
Withdrawn NCT00323570 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma Phase 3
Completed NCT00127283 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 3
Completed NCT01563523 - Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients Phase 2
Terminated NCT01564563 - Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation Phase 2
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Completed NCT01601613 - Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever Phase 2
Completed NCT00266006 - Factor VIIa in Acute Intracerebral Haemorrhage Phase 2
Completed NCT00123591 - Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury Phase 2
Completed NCT01562574 - Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease Phase 3
Completed NCT01285089 - Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia N/A
Terminated NCT00154427 - Use of Activated Recombinant Human Factor VII in Cardiac Surgery Phase 2