Brief Title
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
Official Title
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
Brief Summary
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Maximum ankle MRI score
Secondary Outcome
Total MRI score of the maximum index joint
Condition
Hemophilia A
Intervention
No Drug
Study Arms / Comparison Groups
Arm 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
156
Start Date
June 2009
Completion Date
December 2010
Primary Completion Date
December 2010
Eligibility Criteria
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
Gender
Male
Ages
12 Years - 35 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00927667
Organization ID
12948
Secondary IDs
2009-010147-14
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
February 2013