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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1198-6270 | Other Identifier | World Health Organization (WHO) |
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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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haemophilia B | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refixia® | Drug | Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Reactions (ARs) | Count of events | From baseline (week 0) to end of study (up to 6 years and 10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | Count of events | From baseline (week 0) to end of study (up to 6 years and 10 months) |
| Number of Serious Adverse Reactions (SARs) | Count of events |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia B
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Søborg | Denmark | ||||
| Nagoya University Hospital_Blood Transfusion |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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 | 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 | 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. | 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. | From baseline (week 0) to end of study (up to 6 years and 10 months) |
| Aichi |
| 466-8560 |
| Japan |
| Aomori Prefectural Central Hospital_Pediatrics | Aomori | 030-8553 | Japan |
| Matsudo City General Hospital_Pediatrics | Chiba | 270-2296 | Japan |
| Japan Red Cross Narita Hospital_Hematology and Oncology | Chiba | 286-8523 | Japan |
| Chiba University Hospital_Diabetes, Metabolism and Endocrinology | Chiba-shi, Chiba | 260-8677 | Japan |
| Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy | Hyōgo | 654-0047 | Japan |
| Tokyo Medical University Ibaraki Medical Center_Ibaraki | Ibaraki | 300-0395 | Japan |
| Ishikawa Prefectural Central Hospital_Haematology | Ishikawa | 920-8530 | Japan |
| St. Marianna University School of Medicine Hospital_Pediatrics | Kanagawa | 216-8511 | Japan |
| Kitasato University Hospital_Blood Transfusion | Kanagawa | 252-0375 | Japan |
| Hospital of the University of Occupational And Environmental Health Japan_Pediatrics | Kitakyusyu-shi, Fukuoka | 807 8555 | Japan |
| Gunma University Hospital_Hematology | Maebashi-shi, Gunma | 371-8511 | Japan |
| Naha City Hospital_Cardiovascular Medicine | Naha-shi, Okinawa | 902-8511 | Japan |
| Nara Medical University Hospital_Pediatrics | Nara | 634-8522 | Japan |
| The Hospital of Hyogo College of Medicine_Haematology | Nishinomiya-shi, Hyogo | 663 8051 | Japan |
| Saitama Children's Med Centre_Hematology-Oncology | Saitama | 330-8777 | Japan |
| Tokushima University Hospital_Pediatrics | Tokushima | 770-8503 | Japan |
| Tokushima Red Cross Hospital_Pediatrics | Tokushima | 773-8502 | Japan |
| Tokyo Medical Univ. Hospital_Laboratory Medicine | Tokyo | 160-0023 | Japan |
| Ogikubo Hospital_Blood Coagulation | Tokyo | 167-0035 | Japan |
| Ishiyama Clinic | Yamagata | 992-0035 | Japan |
| St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept, | Yokohama-shi, Kanagawa | 241-0811 | Japan |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |