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