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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2002-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Acquired Bleeding Disorder Intracerebral Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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activated recombinant human factor VII

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult

Interventions

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activated recombinant human factor VII

Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult

Intervention Type DRUG

placebo

Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No