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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01566786
First received: March 27, 2012
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Acquired Bleeding Disorder
Intracerebral Haemorrhage
Drug: activated recombinant human factor VII
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in ICH volume as measured by CT head scans [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of adverse events [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2001
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: activated recombinant human factor VII 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 Comparator: Placebo 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566786

Locations
Australia
Parkville, Australia, 3052
Germany
Heidelberg, Germany, 60120
Italy
Roma, Italy, 00185
Singapore
Singapore, Singapore, 308443
Spain
Girona, Spain, 17007
Taiwan
Taiwan, Taiwan
United Kingdom
Newcastle, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Nikolai C. Brun Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01566786     History of Changes
Other Study ID Numbers: F7ICH-1389
Study First Received: March 27, 2012
Last Updated: March 29, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Cerebral Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 10, 2014