Clinical Trial: Trial of NovoSeven® in Haemophilia - Joint Bleeds
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Do
Brief Summary: This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Comparison with FEIBA on review of pain, joint mobility and circumference [ Time Frame: after 1, 3, 6, and 9 hours of treatment, respectively ]
Original Primary Outcome: Comparison with FEIBA
Current Secondary Outcome: Safety variables
Original Secondary Outcome:
Information By: Novo Nordisk A/S
Dates:
Date Received: April 18, 2005
Date Started: September 2001
Date Completion:
Last Updated: January 11, 2017
Last Verified: January 2017