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:

ClinicalTrials.gov Identifier:

NCT01563445

First Posted: March 27, 2012

Last Update Posted: January 13, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novo Nordisk A/S

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 (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

Information from the National Library of Medicine

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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

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


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:

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

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.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01563445 History of Changes
Other Study ID Numbers:	F7ICH-2073
First Submitted:	March 23, 2012
First Posted:	March 27, 2012
Last Update Posted:	January 13, 2017
Last Verified:	January 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

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