Clinical Trial: Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia

Brief Summary: This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven® ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time proportion of acute bleeding treatments resulting in effective pain relief [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® ]
  • Proportion of patients experiencing one or more re-bleeds [ Time Frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding) ]


Original Secondary Outcome:

  • Proportion of acute bleeding treatments resulting in effective pain relief [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® ]
  • Proportion of patients experiencing one or more re-bleeds [ Time Frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding) ]


Information By: Novo Nordisk A/S

Dates:
Date Received: June 11, 2008
Date Started: June 2008
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016