A Prospective, Non-Interventional Study to investigate the Effectiveness of AFSTYLA® in Patients with Hemophilia A
- Conditions
- D66Hereditary factor VIII deficiency
- Registration Number
- DRKS00017369
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 52
• The treatment decision was made by the attending physician in accordance with standard medical practice and independently of this study
• Written and personally dated consent of the patient or for minors of the legal representative after a detailed explanation of the observational study by the attending physician. The consent must correspond to the presumed will of the minor, if one can be determined. The underage patient should also be given the opportunity to consent in writing, provided that his / her age allows to do so according to the physician
• diagnosed with Hemophilia A
• treatment with AFSTYLA® according to the medical practice and the latest product information for the treatment and prevention of bleeding events
• currently participating in a clinical trial
• known hypersensitivity to the active substance or other ingredients
• known allergic reaction to hamster proteins
• presence of inhibitors to FVIII or to AFSTYLA® (from = 0,6 BE /ml) and/or immune tolerance treatment at the time of recruitment
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - annualized bleeding rate (ABR) for all bleeds, <br>- annualized spontaneous bleeding rate (AsBR), <br>- hemostatic effectiveness of AFSTYLA® for the treatment of bleeding episodes (number of injections and dose required)<br>- investigator’s rating of hemostatic effectiveness of AFSTYLA® for prophylaxis, prevention of bleeding episodes in times with risk and on-demand treatment by a 4-point-verbal-rating-scale
- Secondary Outcome Measures
Name Time Method