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Clinical Trials/NCT01566786
NCT01566786CompletedPhase 2

Randomised, Double-Blind, Placebo-Controlled, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage

Novo Nordisk A/S1 site in 1 country48 target enrollmentStarted: August 2001Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Change in ICH volume as measured by CT head scans
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

activated recombinant human factor VII

Experimental

Intervention: activated recombinant human factor VII (Drug)

Placebo

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Change in ICH volume as measured by CT head scans

Secondary Outcomes

  • Occurrence of adverse events
  • Occurrence of serious adverse events

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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