BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
A Prospective Controlled Study on the Effect on Bleeding Events and Joint Function in Young Adults With Severe Hemophilia A After a 6 Month Prophylaxis Treatment Compared to on Demand Treatment
The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design. In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.
Number of Joint Bleeds
Number of All Bleeds
Study Arms / Comparison Groups
rFVIII-FS (octocog-alfa), (Kogenate FS)
Description: On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Severe hemophilia A (< 1% FVIII) - 30-45 years of age - Previously treated subject (> 100 Exposure days to any FVIII) - On-demand therapy with any FVIII Exclusion Criteria: - No history of inhibitor - No planned elective orthopedic surgery during the study duration (13 months) - No severe concomitant disease - No history of anaphylactic or other severe reaction to previous FVIII treatment
30 Years - 45 Years
Accepts Healthy Volunteers
Bayer Study Director, ,
Bayer Study Director, Study Director, Bayer