Clinical Trial: Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: 24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia
Brief Summary: The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.
Detailed Summary:
Sponsor: Swedish Orphan Biovitrum
Current Primary Outcome:
- Annualised bleeding rate (ABR) [ Time Frame: 24 months ]
- Annualised injection frequency [ Time Frame: 24 months ]
- Annualised factor consumption (International Unit [IU]) [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Swedish Orphan Biovitrum
Dates:
Date Received: November 24, 2016
Date Started: October 2016
Date Completion: September 2020
Last Updated: February 2, 2017
Last Verified: February 2017
