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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1286-2960 | Other Identifier | Universal trial number |
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The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years. Participants enrolment will be completed in the first 4 years. The observation period of this study will last for about 2 years for each enrolled participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concizumab | Participants with haemophilia A or haemophilia B without inhibitors will be be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concizumab | Drug | Participants will be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Alhemo is made at the physician's discretion before and independently from this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse reaction (AR) | Count of adverse reaction. | From baseline (week 0) to end of study (week 104) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse reaction (SAR) | Count of serious adverse reaction. | From baseline (week 0) to end of study (week 104) |
| Number of serious adverse event (SAE) | Count of serious adverse event. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with haemophilia A or haemophilia B without inhibitors will be be treated with commercially available Alhemo 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 |
|---|---|---|---|---|---|---|
| Chiba university hospital_Pediatrics | Chiba | 260-8677 | Japan | |||
| National Hospital Organization Awara Hospital_Hematology and Oncology |
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) | Count of thromboembolic adverse event. | From baseline (week 0) to end of study (week 104) |
| Number of shock/anaphylaxis adverse event (AE) | Count of shock/anaphylaxis adverse event. | From baseline (week 0) to end of study (week 104) |
| Number of treated spontaneous and traumatic bleeding episodes | Count of treated spontaneous and traumatic bleeding episodes. | From baseline (week 0) to end of study (week 104) |
| Number of treated spontaneous and traumatic target joint bleeding episodes | Count of treated spontaneous and traumatic target joint bleeding episodes. | From baseline (week 0) to end of study (week 104) |
| Number of all treatment requiring bleeding episodes | Count of all treatment requiring bleeding episodes. | From baseline (week 0) to end of study (week 104) |
| Fukui |
| 910-4272 |
| Japan |
| Hoshi General Hospital_Pediatrics | Fukushima | 963-8501 | Japan |
| Hyogo Prefectural Amagasaki General Medical Center_Haematology | Hyōgo | 660-8550 | Japan |
| St. Marianna University School of Medicine Hospital_Pediatrics | Kanagawa | 216-8511 | Japan |
| Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy | Kawagoe | Japan |
| Miyagi Children's Hospital_Hematology-Oncology | Miyagi | 989-3126 | Japan |
| Nagano Children's Hospital_Hematology-Oncology | Nagano | 399-8288 | Japan |
| Nagano red cross hospital_Pediatrics | Nahano | 380-8582 | Japan |
| Nanbu Medical Center & Children's Medical Center_Pediatric Hematology | Okinawa | 901-1193 | Japan |
| Arin Clinic Shonika_Pediatrics | Okinawa | 901-2132 | Japan |
| University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology | Okinawa | 901-2725 | Japan |
| Kansai Medical University Hospital_Pediatrics | Osaka | 573-1191 | Japan |
| Saitama Children's Med Centre_Hematology-Oncology | Saitama | 330-8777 | Japan |
| Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy | Saitama | 350-8550 | Japan |
| Fukaya Red Cross Hospital_Haematology | Saitama | 366-0052 | Japan |
| Matsue red cross hospital_Pediatrics | Shimane | 690-8506 | Japan |
| Hamamatsu Medical Center_Pediatrics | Shizuoka | 432-8580 | Japan |
| Iwata City Hospital_Haematology | Shizuoka | 438-8550 | Japan |
| National Center for Child Health and Development_Hematology | Tokyo | 157-8535 | 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 |
| 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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