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

Phase 2

Completed

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

• Registration Number: NCT01563445
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Occurrence of a treatment-related serious adverse event (SAE)

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events
Change in ICH volume as measured by CT head scans

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 New York, New York, United States