Overview

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

Status:
Completed

Trial end date:
2002-10-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novo Nordisk A/S

Criteria

Inclusion Criteria:

- Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of
onset

- Signed informed consent form, or in countries where waiver of informed consent is
allowed by IRB/IEC, a completed waiver form

Exclusion Criteria:

- Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT

- Patients with secondary ICH related to infarction, haemophilia or other coagulopathy,
tumour, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm,
arteriovenous malformations (AVM) or severe trauma

- Surgical haematoma evacuation planned or performed within 24 hours of onset