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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563445
First Posted: March 27, 2012
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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).

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Occurrence of a treatment-related serious adverse event (SAE)

Secondary Outcome Measures:
  • Occurrence of adverse events
  • Change in ICH volume as measured by CT head scans

Enrollment: 40
Study Start Date: November 2001
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: activated recombinant human factor VII Drug: activated 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
Placebo Comparator: Placebo Drug: placebo
Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563445


Locations
United States, New York
Novo Nordisk Investigational Site
New York, New York, United States, 10032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01563445     History of Changes
Other Study ID Numbers: F7ICH-2073
First Submitted: March 23, 2012
First Posted: March 27, 2012
Last Update Posted: January 13, 2017
Last Verified: January 2017

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