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

Multi-center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) for Preventing Early Hematoma Growth in Acute Intracerebral Hemorrhage (ICH)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01563445

Enrollment

Registered

2012-03-27

Start date

2001-11-30

Completion date

2003-03-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Intracerebral Haemorrhage

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).

Interventions

DRUGactivated recombinant human factor VII

Subjects will be randomised to receive a single intravenous dose of either 5, 20, 40 and 80 mcg/kg body weight. Administered within the first 4 hours after the insult

DRUGplacebo

Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Occurrence of a treatment-related serious adverse event (SAE)	—

Secondary

Measure	Time frame
Occurrence of adverse events	—
Change in ICH volume as measured by CT head scans	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026