- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01563445
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
January 12, 2017 updated by: Novo Nordisk A/S
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Subjects will be randomised to receive a single intravenous dose.
Administered within the first 4 hours after the insult
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Experimental: activated recombinant human factor VII
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Occurrence of a treatment-related serious adverse event (SAE)
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Secondary Outcome Measures
Outcome Measure |
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Occurrence of adverse events
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Change in ICH volume as measured by CT head scans
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
- Diringer MN, Skolnick BE, Mayer SA, Steiner T, Davis SM, Brun NC, Broderick JP. Risk of thromboembolic events in controlled trials of rFVIIa in spontaneous intracerebral hemorrhage. Stroke. 2008 Mar;39(3):850-6. doi: 10.1161/STROKEAHA.107.493601. Epub 2008 Jan 31.
- Mayer SA, Brun NC, Broderick J, Davis SM, Diringer MN, Skolnick BE, Steiner T; United States NovoSeven ICH Trial Investigators. Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial. Neurocrit Care. 2006;4(3):206-14. doi: 10.1385/NCC:4:3:206.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Actual)
March 1, 2003
Study Completion (Actual)
March 1, 2003
Study Registration Dates
First Submitted
March 23, 2012
First Submitted That Met QC Criteria
March 23, 2012
First Posted (Estimate)
March 27, 2012
Study Record Updates
Last Update Posted (Estimate)
January 13, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Intracranial Hemorrhages
- Hemostatic Disorders
- Blood Coagulation Disorders
- Hemorrhage
- Cerebral Hemorrhage
- Hematoma
Other Study ID Numbers
- F7ICH-2073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseGermany
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Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Bleeding During/Following SurgeryIsrael, Sweden, United Kingdom, Germany, Switzerland, France, Spain, Italy, Thailand, Denmark, United States, Poland, Finland, Singapore, Australia, Austria
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Novo Nordisk A/STerminatedAcquired Bleeding Disorder | Bleeding During/Following SurgeryUnited States
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Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Bleeding During/Following SurgeryGermany, Sweden, United Kingdom, Spain, Canada, Australia, France
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Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Acquired HaemophiliaFrance
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Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderGermany, Austria, Israel, France, Canada, Singapore, South Africa, Australia, United Kingdom
-
Novo Nordisk A/STerminatedAcquired Bleeding Disorder | Cardiac Surgery Requiring Cardiopulmonary BypassUnited States, Spain, Germany, Sweden, United Kingdom, Argentina, Italy, Brazil, Denmark, France, India, Malaysia, Singapore, South Africa
-
Novo Nordisk A/SCompletedHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseFrance
-
Novo Nordisk A/STerminatedTrauma | Acquired Bleeding DisorderSpain, Hong Kong, Germany, France, United Kingdom, Brazil, Italy, Hungary, Netherlands, United States, Switzerland, Czech Republic, Greece, South Africa
-
Novo Nordisk A/SWithdrawnTrauma | Acquired Bleeding DisorderUnited States
Clinical Trials on activated recombinant human factor VII
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Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderUnited States, Canada
-
Novo Nordisk A/SCompletedHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseFrance
-
Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Intracerebral HaemorrhageSpain, Sweden, Singapore, Norway, Italy, Switzerland, Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Netherlands, United Kingdom
-
Novo Nordisk A/SCompletedHealthy | Congenital Bleeding DisorderUnited States
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A | Haemophilia BFrance, Israel, Germany
-
Novo Nordisk A/SCompletedOther Haemostasis Disorder | Haemorrhagic CystitisUnited States
-
Novo Nordisk A/STerminatedAcquired Bleeding Disorder | Cardiac Surgery Requiring Cardiopulmonary BypassUnited States, Spain, Germany, Sweden, United Kingdom, Argentina, Italy, Brazil, Denmark, France, India, Malaysia, Singapore, South Africa
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With InhibitorsFrance, United Kingdom, Spain, Israel, Poland, Turkey, Hungary
-
Novo Nordisk A/SCompletedObservational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII DeficiencyCongenital Bleeding Disorder | Congenital FVII DeficiencyJapan
-
Novo Nordisk A/SCompletedCirrhosis | Acquired Bleeding DisorderGermany, United Kingdom, Spain, Taiwan, France, Italy, Austria, Czech Republic, Poland, Denmark, Finland, Hong Kong