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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Intracerebral Haemorrhage; Acquired Bleeding Disorder

Treatments: Drug: placebo; Drug: activated recombinant human factor VII

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563445

F7ICH-2073

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

activated recombinant human factor VII

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Placebo

Placebo Comparator group

Treatment:

Drug: placebo