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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Intracerebral Haemorrhage; Acquired Bleeding Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01566786

F7ICH-1389

Details and patient eligibility

About

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).

Enrollment: 48 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 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