A prospective, non-interventional study to investigate the effectiveness of a recombinant fusion protein linking coagulation Factor IX with recombinant albumin (rIX-FP) in patients with hemophilia B
- Conditions
- D67Hereditary factor IX deficiency
- Registration Number
- DRKS00015079
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
• Factor IX deficiency.
• Treatment with IDELVION® according to routine practice and according to the current SmPC (The decision for IDELVION® therapy was made independent of this NIS)
• Written and personally dated informed consent of the patient or in case of minors of one parent or legal guardian after receiving detailed information about the observational study by the treating physician. Minors should also sign the informed consent, if his/her age allows it.
Exclusion Criteria
• Existing inhibitor development.
• Existing multi-factor-deficiency
• simultaneous participation in an interventional study
• Known hypersensitivity to any ingredient of the FIX product or hamster protein
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Assessment of the number of bleedings regardless their etiology (annualized bleeding rate ABR)<br>•Assessment of the number of spontaneous haemophilic bleedings (annualized spontaneous bleeding rate AsBR)
- Secondary Outcome Measures
Name Time Method •Assessment of IDELVION® therapy in routine practice (Frequency and Dosage of injections for prophylaxis and on-demand treatment)<br>•Assessment of IDELVION® effectiveness in the treatment of bleedings<br>•Assessment of quality of life through standardized questionnaires: Haem-A-QoL for adults and Haemo-QoL for children and adolescents<br>•Assessment of safety and tolerability of IDELVION®<br>•Assessment of patient satisfaction<br>•Assessment of health-economical aspects