Post-marketing Surveillance (Use Result Surveillance) With Refixia®

Brief Summary: 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®.

Recruitment & Eligibility

Inclusion Criteria

Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
The decision to initiate treatment with commercially available Refixia® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. At each site of this study, all patients will be registered consecutively from the first patient after the launch of Refixia® (consecutively registered system).
Diagnosis of haemophilia B in males or females, no age limitation. Patients younger than 12 years old will continue to be registered for 3 years of recruitment period regardless of the target number of patients.
New patients who have not been previously exposed to Refixia®. Also patients previously exposed to Refixia® in NN7999-3639, -3747, -3774, -3775 or -3895 clinical trial can be enrolled in this study. The patients who have participated in NN7999 -3774 or -3895 clinical trial can be enrolled in this study as continuous cases until 30-September-2024 (one year before planned end of study date).

Exclusion Criteria

Previous participation in this study. Participation is defined as having given informed consent in this study
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Known or suspected hypersensitivity to study product or related products.

Arm && Interventions

Group	Intervention	Description
Patients with haemophilia B	Refixia®	Both patients who have not previously been exposed to Refixia® and patients previously exposed to Refixia® in one of the clinical trials can be included.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Reactions (ARs)	From baseline (week 0) to end of study (up to 6 years and 10 months)	Count of events

Secondary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events (SAEs)	From baseline (week 0) to end of study (up to 6 years and 10 months)	Count of events
Number of treatment requiring bleeding episodes as assessed by ABR	From baseline (week 0) to end of study (up to 6 years and 10 months)	Count of bleeding episodes
Number of Serious Adverse Reactions (SARs)	From baseline (week 0) to end of study (up to 6 years and 10 months)	Count of events
Haemostatic response of Refixia® in treatment of bleeds in perioperative management during surgical procedures	From baseline (week 0) to end of study (up to 6 years and 10 months)	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.
Number of bleeding episodes as assessed by annualised bleeding rate (ABR)	From baseline (week 0) to end of study (up to 6 years and 10 months)	Count of bleeding episodes
Haemostatic response of Refixia® in treatment of bleeds	From baseline (week 0) to end of study (up to 6 years and 10 months)	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.

Locations (17): Novo Nordisk Investigational Site
🇩🇰
Søborg, Denmark
Nagoya University Hospital_Blood Transfusion
🇯🇵
Aichi, Japan
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
🇯🇵
Chiba-shi, Chiba, Japan
St. Marianna University School of Medicine Hospital_Pediatrics
🇯🇵
Kanagawa, Japan
Hyogo prefectural kobe children's hospital
🇯🇵
Hyogo, Japan
Tokyo Medical University Ibaraki Medical Center_Ibaraki
🇯🇵
Ibaraki, Japan
Kitasato University Hospital
🇯🇵
Kanagawa, Japan
Hospital of the University of Occupational And Environmental Health Japan, Pediatrics
🇯🇵
Kitakyusyu-shi, Fukuoka, Japan
Gunma University Hospital, Dept. of Hematology
🇯🇵
Maebashi-shi, Gunma, Japan
Naha City Hospital
🇯🇵
Naha-shi, Okinawa, Japan
Saitama Children's Med Centre_Hematology-Oncology
🇯🇵
Saitama, Japan
Nara Medical University Hospital_Pediatrics
🇯🇵
Nara, Japan
Tokushima Red Cross Hospital
🇯🇵
Tokushima, Japan
The Hospital of Hyogo College of Medicine
🇯🇵
Nishinomiya-shi, Hyogo, Japan
Tokyo Medical Univ. Hospital_Laboratory Medicine
🇯🇵
Tokyo, Japan
Ogikubo Hospital_Tokyo
🇯🇵
Tokyo, Japan
Ishiyama Clinic
🇯🇵
Yamagata, Japan