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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1274-4740 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concizumab | Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. Recruitment will be completed after 4.5 years from the launch of Concizumab. The observation period for each participant is 2 years. Total duration of this study is about 6.5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concizumab | Drug | Participants will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Concizumab has been made by the participant/ legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse reaction (AR) | Measured as count of ARs. | From baseline (week 0) to end of study (week 104) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse reaction (SAR) | Measured as count of SARs. | From baseline (week 0) to end of study (week 104) |
| Number of serious adverse event (SAE) | Measured as count of SAEs. |
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Inclusion Criteria:
Exclusion Criteria:
- Previous participation in this study. Participation is defined as having given informed consent in this study
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Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available concizumab according to routine clinical practice at the discretion of the treating physician.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Toshima City | Tokyo | Japan | |||
| Mutsu general hospital_Pediatrics |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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|
|
| From baseline (week 0) to end of study (week 104) |
| Number of thromboembolic adverse event (AE) | Measured as count of thromboembolic AEs. | From baseline (week 0) to end of study (week 104) |
| Number of shock/anaphylaxis AE | Measured as count of shock/anaphylaxis AEs. | From baseline (week 0) to end of study (week 104) |
| Number of treated spontaneous and traumatic bleeding episodes | Measured as count of bleeding episodes. | From baseline (week 0) to end of study (week 104) |
| Number of treated spontaneous and traumatic target joint bleeding episodes | Measured as count of bleeding episodes. | From baseline (week 0) to end of study (week 104) |
| Number of all treatment requiring bleeding episode | Measured as count of bleeding episodes. | From baseline (week 0) to end of study (week 104) |
| Aomori |
| 035-8601 |
| Japan |
| Kyushu university hospital_Pediatrics | Fukuoka | 812-8582 | Japan |
| Sapporo Tokushukai Hospital_Pediatrics | Hokkaido | 004-0041 | Japan |
| Kagoshima City Hospital_Pediatrics | Kagoshima | 890-8760 | Japan |
| St. Marianna University School of Medicine Hospital_Pediatrics | Kanagawa | 216-8511 | Japan |
| Hospital of the University of Occupational And Environmental Health Japan_Pediatrics | Kitakyusyu-shi, Fukuoka | 807 8555 | Japan |
| Nanbu Medical Center & Children's Medical Center_Hematology and Oncology | Okinawa | 901-1193 | Japan |
| University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology | Okinawa | 901-2725 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Ogikubo Hospital_Blood Coagulation | Tokyo | 167-0035 | Japan |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| C574488 | concizumab |
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