Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage

Acquired Bleeding Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563445
• Other study ID #: F7ICH-2073
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2012
• Last updated: January 12, 2017
• Start date: November 2001
• Est. completion date: March 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Cerebral Hemorrhage
• Hematoma
• Hemorrhage
• Hemostatic Disorders
• Intracerebral Haemorrhage

Intervention

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
Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a treatment-related serious adverse event (SAE)
Secondary	Occurrence of adverse events
Secondary	Change in ICH volume as measured by CT head scans

External Links

•   Clinical Trials at Novo Nordisk