Clinical Trial: Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors
Brief Summary: This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome:
- Number of bleeds managed at home [ Time Frame: Month 8 ]
- Number of treatments resulting in the control of bleeding episode [ Time Frame: within 9 hours after the first injection of study product ]
- Number of treatments resulting in effective pain relief [ Time Frame: within 9 hours after the first injection of study product ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home [ Time Frame: Month 8 ]
- Proportion of patients who used their entire treatment at home [ Time Frame: Month 8 ]
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: November 3, 2010
Date Started: October 2010
Date Completion:
Last Updated: November 13, 2014
Last Verified: November 2014