NCT01566786|CompletedPhase 2

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

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/S ClinicalTrials.gov

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1 other identifier

F7ICH-1389

Study Type

interventional

Target

Locations

9 countries

Sites

Timeline

RegisteredMar 2012

StartedAug 2001

CompletionOct 2002

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Aug 2001

Shorter than P25 for phase_2

Geographic Reach

9 countries

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

August 1, 2001

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed

9.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed

Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

March 27, 2012

Last Update Submit

January 11, 2017

Conditions

Acquired Bleeding Disorder Intracerebral Haemorrhage

Outcome Measures

Primary Outcomes (1)

Change in ICH volume as measured by CT head scans

Secondary Outcomes (2)

Occurrence of adverse events
Occurrence of serious adverse events

Study Arms (2)

activated recombinant human factor VII

EXPERIMENTAL

Drug: activated recombinant human factor VII

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

activated recombinant human factor VIIDRUG

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

activated recombinant human factor VII

placeboDRUG

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.