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

Phase 2

Completed

• Conditions: Acquired Bleeding Disorder; Intracerebral Haemorrhage
• Interventions: Drug: activated recombinant human factor VII; Drug: placebo

• Registration Number: NCT01566786
• Lead Sponsor: Novo Nordisk A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2002-10
• Study Completion: 2002-10
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
activated recombinant human factor VII	activated recombinant human factor VII	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change in ICH volume as measured by CT head scans

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events
Occurrence of serious adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Newcastle, United Kingdom