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

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ClinicalTrials.gov Identifier: NCT01563445
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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)
Study Start Date : November 2001
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, New York
Novo Nordisk Investigational Site
New York, New York, United States, 10032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:
Mayer SA, Brun NC, Broderick J, Diringer MN, Davis SM, Steiner T. Safety and Preliminary Efficacy of Recombinant Coagulation Factor VII in Patients with Acute Intracerebral Hemorrhage. Stroke 2004; 35: 322

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01563445    
Other Study ID Numbers: F7ICH-2073
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Hematoma
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders