Clinical Trial: A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Brief Summary: Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.

Detailed Summary:
Sponsor: Swedish Orphan Biovitrum

Current Primary Outcome:

• Annualised bleeding rate (ABR) [ Time Frame: 24 months ]
  Based on bleeding episodes assessed by local practice
• Annualised injection frequency [ Time Frame: 24 months ]
  Assessed by prescription
• Annualised factor consumption (IU) [ Time Frame: 24 months ]
  Assessed by dispensed factor product

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Swedish Orphan Biovitrum

Dates:
Date Received: February 14, 2017
Date Started: April 2017
Date Completion: August 2020
Last Updated: April 4, 2017
Last Verified: April 2017