Clinical Trial: High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Mu

Brief Summary: This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: Global treatment response of the patient by an algorithm based pain and joint mobility assessments

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain assessment
  • Mobility assessment
  • Circumference of joint
  • Adverse events


Original Secondary Outcome: Same as current

Information By: Novo Nordisk A/S

Dates:
Date Received: December 11, 2007
Date Started: November 2002
Date Completion:
Last Updated: January 11, 2017
Last Verified: January 2017