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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1216-4626 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haemophilia A | New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turoctocog alfa pegol | Drug | Patients will be treated with commercially available Esperoct® according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse reactions (ARs) reported during the observation period | Count | From baseline (week 0) to end of study (week 104) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events (SAEs) reported during the observation period | Count | From baseline (week 0) to end of study (week 104) |
| Number of serious adverse reactions (SARs) reported during the observation period |
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Inclusion Criteria:
Exclusion Criteria:
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Haemophilia A patients in routine clinical practice in Japan
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor & Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurume University Hospital, Pediatrics | Fukuoka | 830-0011 | Japan | |||
| Gifu University Hospital_The Third Dept. of Internal Medicine |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Count
| From baseline (week 0) to end of study (week 104) |
| Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period | Count | From baseline (week 0) to end of study (week 104) |
| Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR) | Count | From baseline (week 0) to end of study (week 104) |
| Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds | Count, assessed 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 (week 104) |
| Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures | Count, assessed as success/failure based on a four-point scale for haemostatic response (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 (week 104) |
| Gifu |
| 501-1194 |
| Japan |
| Gifu University Hospital | Gifu | 501-1194 | Japan |
| Saitama Medical University Hospital, Pediatrics | Iruma-gun, Saitama | 350 0495 | Japan |
| University Hospital Kyoto Prefectual University of Medicine | Kamigyo-ku, Kyoto | 602-8566 | Japan |
| St. Marianna University School of Medicine Hospital_Pediatrics | Kanagawa | 216-8511 | Japan |
| St. Marianna University School of Medicine Hospital | Kanagawa | 216-8511 | Japan |
| Nara Medical University Hospital_Pediatrics | Nara | 634-8522 | Japan |
| Nanbu Medical Center & Children's Medical Center_Pediatric Hematology | Okinawa | 901-1193 | Japan |
| Shibuya Children's Clinic, Department of Pediatric | Saitama | 350-0225 | Japan |
| Lake Children Clinic | Shiga | 520-2145 | Japan |
| Shizuoka Children's Hospital, Hematology-Oncology | Shizuoka | 420-8660 | Japan |
| Shizuoka Children's Hospital | Shizuoka | 420-8660 | Japan |
| Nippon Medical School Hospital_Haematology | Tokyo | 113-8603 | Japan |
| Tokyo Medical Univ. Hospital_Laboratory Medicine | Tokyo | 160-0023 | Japan |
| Tokyo Medical Univ. Hospital | Tokyo | 160-0023 | Japan |
| Ogikubo Hospital_Blood Coagulation | Tokyo | 167-0035 | Japan |
| Nihonkai Sogo Hospital_Internal Medicine | Yamagata | 998-8501 | Japan |
| Nihonkai Sogo Hospital | Yamagata | 998-8501 | 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 |