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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1162-5426 | Other Identifier | WHO |
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This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovoThirteen® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant factor XIII | Drug | No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect | Year 0-9 |
| Measure | Description | Time Frame |
|---|---|---|
| All serious adverse events | Year 0-9 | |
| All adverse events | Year 0-9 | |
| All medical event of special interest |
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Inclusion Criteria:
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Male or female patients, regardless of age, requiring treatment with NovoThirteenR 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 |
|---|---|---|---|---|---|---|
| Nagoya University Hospital_Blood Transfusion | Aichi | 466-8560 | Japan | |||
| Gamagori Hospital |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Year 0-9 |
| All medication errors collected | Year 0-9 |
| All technical complaints | Year 0-9 |
| Use of NovoThirteen® for other uses than for the approved indication | Year 0-9 |
| Frequency of bleeding episodes | Year 0-9 |
| Gamagori-shi, Aichi |
| 443-8501 |
| Japan |
| Chugoku Central Hospital | Hiroshima | 720-0001 | Japan |
| Kure Medical Center and Chugoku Cancer Center | Kure-shi, Hiroshima | 737-0023 | Japan |
| Nikko Memorial Hospital | Muroran, Hokkaido, | 051-8501 | Japan |
| Saitama Children's Med Centre_Hematology-Oncology | Saitama | 330-8777 | Japan |
| Takashima Municipal Hospital | Shiga | 520-1121 | Japan |
| Ogikubo Hospital_Pediatries & Blood | Tokyo | 167-0035 | Japan |
| ID | Term |
|---|---|
| C521905 | recombinant factor XIII-A2 |
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