Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

• ClinicalTrials.gov Identifier: NCT00127283
• Recruitment Status: Completed
• First Posted: August 5, 2005
• Last Update Posted: January 12, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: August 3, 2005
• First Posted Date: August 5, 2005
• Last Update Posted Date: January 12, 2017
• Study Start Date: May 2005
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 5, 2007): Reducing disability and improving clinical outcome [ Time Frame: After 3 months ]
• Original Primary Outcome Measures (submitted: August 3, 2005): Reducing disability and improving clinical outcome

Current Secondary Outcome Measures (submitted: November 14, 2006)

• Reducing mortality
• Reducing hematoma growth

Original Secondary Outcome Measures (submitted: August 3, 2005)

• Reducing hematoma growth
• Reducing mortality

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
• Official Title: Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

Brief Summary

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.

The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Acquired Bleeding Disorder
• Intracerebral Haemorrhage

• Intervention: Drug: eptacog alfa (activated)
• Study Arms: Not Provided

Publications *

• Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
• Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2011): 829
• Original Enrollment (submitted: August 3, 2005): 675
• Actual Study Completion Date: January 2007
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

• Patients with secondary ICH
• Pre-existing disability
• Haemophilia

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United States
• Removed Location Countries: Argentina, Mexico, United Kingdom

Administrative Information

• NCT Number: NCT00127283
• Other Study ID Numbers: F7ICH-1641; 2004-004202-24 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novo Nordisk A/S
• Study Sponsor: Novo Nordisk A/S
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: January 2017