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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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01563445
First received: March 23, 2012
Last updated: January 12, 2017
Last verified: January 2017

March 23, 2012
January 12, 2017
November 2001
March 2003   (Final data collection date for primary outcome measure)
Occurrence of a treatment-related serious adverse event (SAE)
Same as current
Complete list of historical versions of study NCT01563445 on ClinicalTrials.gov Archive Site
  • Occurrence of adverse events
  • Change in ICH volume as measured by CT head scans
Same as current
Not Provided
Not Provided
 
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
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)
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Intracerebral Haemorrhage
  • 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
  • Drug: placebo
    Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult
  • Experimental: activated recombinant human factor VII
    Intervention: Drug: activated recombinant human factor VII
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2003
March 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01563445
F7ICH-2073
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP