Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
A Diagnostic Interventional, Controlled, Cross-sectional Evaluation of Joint Status Using Magnetic Resonance Imaging in Subjects With Severe Hemophilia A Treated With Primary Prophylaxis, Secondary Prophylaxis, or On-demand Therapy
The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.
Maximum ankle MRI score
Total MRI score of the maximum index joint
Study Arms / Comparison Groups
* 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: - Males aged 12 - 35 years - Severe hemophilia A ( < 1 % FVIII:C) - No history of Factor VIII inhibitory antibody - For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present. - Complete documentation of joints bleeds and their locations prior to start of prophylaxis, - Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records. - For the on-demand subjects > 12 bleeds/year in the last 5 years. - Written informed consent by subject and parent/legal representative, if < 18 years Exclusion Criteria: - Individuals with other coagulopathies (e.g., von Willebrand disease) - HIV seropositive subjects - Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee) - HCV seropositive individuals who underwent interferon therapy during the last 12 months - Individuals for whom high-magnetic exposure is contraindicated (see section 7.1) - Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period - Joint replacement - For the on-demand treatment group, any period greater than 8 consecutive months having received >/= 50 IU per kg per week Factor VIII for the prevention of bleeding
12 Years - 35 Years
Accepts Healthy Volunteers
Bayer Study Director, ,
Bayer Study Director, Study Director, Bayer