Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage

Multi-center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) for Preventing Early Hematoma Growth in Acute Intracerebral Hemorrhage (ICH)

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).

Inclusion Criteria:

• Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
• Signed informed consent form, or an exception from standard informed consent requirements

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, hemophilia or other coagulopathy, tumor, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, AVM (Arteriovenous Malformation) or severe trauma
• Surgical haematoma evacuation planned or performed within 24 hours of onset