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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:
Novo Nordisk A/S
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
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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 Blind (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:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
Bleeding
Drug Information available for:
Eptacog alfa (activated)
U.S. FDA Resources
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01563445
Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01563445 History of Changes |
| Other Study ID Numbers: |
F7ICH-2073 |
| Study First Received: | March 23, 2012 |
| Last Updated: | January 12, 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 |
ClinicalTrials.gov processed this record on June 28, 2017