The participants are invited to take part in this study because they have Haemophilia B. The purpose of this study is to assess the safety and effectiveness of Refixia® about long-term routine use in patients with Haemophilia B. The participants will get Refixia® as prescribed to them by their study doctor. The study will last up to Sep 2025 for the participant. The participants may be asked to fill in the quality of life questionnaires (if they are above age of 15). The blood samples taken from the participants as part of routine clinical practice will also be used to investigate the safety for the long-term use of Refixia®.
Study Type
OBSERVATIONAL
Enrollment
28
Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician
Novo Nordisk Investigational Site
Søborg, Denmark
Number of Adverse Reactions (ARs)
Count of events
Time frame: From baseline (week 0) to end of study (up to 6 years and 10 months)
Number of Serious Adverse Events (SAEs)
Count of events
Time frame: From baseline (week 0) to end of study (up to 6 years and 10 months)
Number of Serious Adverse Reactions (SARs)
Count of events
Time frame: From baseline (week 0) to end of study (up to 6 years and 10 months)
Number of bleeding episodes as assessed by annualised bleeding rate (ABR)
Count of bleeding episodes
Time frame: From baseline (week 0) to end of study (up to 6 years and 10 months)
Number of treatment requiring bleeding episodes as assessed by ABR
Count of bleeding episodes
Time frame: From baseline (week 0) to end of study (up to 6 years and 10 months)
Haemostatic response of Refixia® in treatment of bleeds
Haemostatic response is assessed as success/failure based on a four-point scale (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure.
Time frame: From baseline (week 0) to end of study (up to 6 years and 10 months)
Haemostatic response of Refixia® in treatment of bleeds in perioperative management during surgical procedures
Haemostatic response is assessed as success/failure based on a four-point scale (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure.
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...and 13 more locations
Time frame: From baseline (week 0) to end of study (up to 6 years and 10 months)