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

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 Genetics related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Bleeding

Drug Information available for: Eptacog alfa (activated)

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

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

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

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

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

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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

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

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

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.

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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

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