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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
Novo Nordisk Investigational Site
Parkville, Victoria, Australia
Novo Nordisk Investigational Site
Copenhagen, Denmark
Novo Nordisk Investigational Site
Jyväskylä, Finland
Novo Nordisk Investigational Site
Heidelberg, Germany
Change in ICH volume as measured by CT head scans
Occurrence of adverse events
Occurrence of serious adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novo Nordisk Investigational Site
Roma, Italy
Novo Nordisk Investigational Site
Singapore, Singapore
Novo Nordisk Investigational Site
Girona, Spain
Novo Nordisk Investigational Site
Dawan, Taiwan
Novo Nordisk Investigational Site
Newcastle, United Kingdom