D67
Conditions
Interventions
Group 1: After giving his/her written informed consent to the observational study each patient will be followed for either 3 years or until 100 exposure days of IDELVION® are reached, whatever occurs
Sponsors
CSL Behring GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Assessment of the number of bleedings regardless their etiology (annualized bleeding rate ABR) •Assessment of the number of spontaneous haemophilic bleedings (annualized spontaneous bleeding rate AsBR) | — |
Secondary
| Measure | Time frame |
|---|---|
| •Assessment of IDELVION® therapy in routine practice (Frequency and Dosage of injections for prophylaxis and on-demand treatment) •Assessment of IDELVION® effectiveness in the treatment of bleedings •Assessment of quality of life through standardized questionnaires: Haem-A-QoL for adults and Haemo-QoL for children and adolescents •Assessment of safety and tolerability of IDELVION® •Assessment of patient satisfaction •Assessment of health-economical aspects | — |
Countries
Germany
Contacts
Public ContactDietmar Pfründer
CSL Behring GmbH
Outcome results
None listed