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Post-marketing Surveillance (Use Result Surveillance) With Refixia®
Sponsor: Novo Nordisk A/S
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®.
Official title: Post-marketing Surveillance (Use Result Surveillance) With Refixia®. A Multicentre, Non-interventional Post Marketing Surveillance of Safety and Effectiveness of Refixia® in Routine Clinical Care With Haemophilia B Patients in Japan.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
28
Start Date
2019-08-23
Completion Date
2025-09-30
Last Updated
2026-04-24
Healthy Volunteers
No
Conditions
Interventions
Refixia®
Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician
Locations (23)
Novo Nordisk Investigational Site
Søborg, Denmark
Nagoya University Hospital_Blood Transfusion
Aichi, Japan
Aomori Prefectural Central Hospital_Pediatrics
Aomori, Japan
Matsudo City General Hospital_Pediatrics
Chiba, Japan
Japan Red Cross Narita Hospital_Hematology and Oncology
Chiba, Japan
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
Chiba-shi, Chiba, Japan
Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy
Hyōgo, Japan
Tokyo Medical University Ibaraki Medical Center_Ibaraki
Ibaraki, Japan
Ishikawa Prefectural Central Hospital_Haematology
Ishikawa, Japan
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, Japan
Kitasato University Hospital_Blood Transfusion
Kanagawa, Japan
Hospital of the University of Occupational And Environmental Health Japan_Pediatrics
Kitakyusyu-shi, Fukuoka, Japan
Gunma University Hospital_Hematology
Maebashi-shi, Gunma, Japan
Naha City Hospital_Cardiovascular Medicine
Naha-shi, Okinawa, Japan
Nara Medical University Hospital_Pediatrics
Nara, Japan
The Hospital of Hyogo College of Medicine_Haematology
Nishinomiya-shi, Hyogo, Japan
Saitama Children's Med Centre_Hematology-Oncology
Saitama, Japan
Tokushima University Hospital_Pediatrics
Tokushima, Japan
Tokushima Red Cross Hospital_Pediatrics
Tokushima, Japan
Tokyo Medical Univ. Hospital_Laboratory Medicine
Tokyo, Japan
Ogikubo Hospital_Blood Coagulation
Tokyo, Japan
Ishiyama Clinic
Yamagata, Japan
St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,
Yokohama-shi, Kanagawa, Japan