Clinical Trial: Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective, Non-interventional, Multi-center, Open-label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Pro
Brief Summary: Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: To evaluate the frequency of all bleeds (spontaneous and trauma) during the study [ Time Frame: End of Study ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To evaluate the change from baseline in HRQoL (health-related quality of life) [ Time Frame: End of Study ]
- To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapy [ Time Frame: End of Study ]
- To evaluate the change from baseline in the Gilbert score [ Time Frame: End of Study ]
- To evaluate the number of target joint development [ Time Frame: End of Study ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: October 29, 2008
Date Started: December 2007
Date Completion:
Last Updated: October 31, 2014
Last Verified: October 2014
