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

Acquired Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566786
• Other study ID #: F7ICH-1389
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2012
• Last updated: January 11, 2017
• Start date: August 2001
• Est. completion date: October 2002

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySingapore: Health Sciences AuthoritySpain: Spanish Agency of MedicinesTaiwan: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Cerebral Hemorrhage
• Hemorrhage
• Hemostatic Disorders
• Intracerebral Haemorrhage

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Parkville	Victoria
Denmark	Novo Nordisk Investigational Site	Copenhagen
Finland	Novo Nordisk Investigational Site	Jyväskylä
Germany	Novo Nordisk Investigational Site	Heidelberg
Italy	Novo Nordisk Investigational Site	Roma
Singapore	Novo Nordisk Investigational Site	Singapore
Spain	Novo Nordisk Investigational Site	Girona
Taiwan	Novo Nordisk Investigational Site	Taiwan
United Kingdom	Novo Nordisk Investigational Site	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Denmark,  Finland,  Germany,  Italy,  Singapore,  Spain,  Taiwan,  United Kingdom, 

References & Publications (1)

Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; Europe/AustralAsia NovoSeven ICH Trial Investigators.. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke. 2005 Jan;36(1):74-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ICH volume as measured by CT head scans			No
Secondary	Occurrence of adverse events			No
Secondary	Occurrence of serious adverse events			No

External Links

•   Clinical Trials at Novo Nordisk