Clinical Trial: Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A
Brief Summary:
Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma inhibitor levels for at least 100 Exposure Days (EDs) for each subject.
Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and adverse events
Detailed Summary:
Sponsor: Bio Products Laboratory
Current Primary Outcome: To assess post-marketing immunogenicity of Optivate by monitoring plasma inhibitor levels for at least 100 Exposure Days for each subject. [ Time Frame: At least 100 Exposure Days for each subject. Subjects will attend 5 visits over a period of up to 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To assess efficacy and tolerability [ Time Frame: Over a period of 12 months ]
Original Secondary Outcome: To assess efficacy and tolerability by monitoring FVIII recovery and adverse events [ Time Frame: Over a period of 12 months ]
Information By: Bio Products Laboratory
Dates:
Date Received: March 13, 2013
Date Started: June 2013
Date Completion: January 2018
Last Updated: December 16, 2016
Last Verified: December 2016
