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| Name | Class |
|---|---|
| Takeda Pharma Korea Co. Ltd. | UNKNOWN |
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The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how effective ADYNOVATE is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries.
Participants with hemophilia A who will be newly prescribed with ADYNOVATE treatment or have already been taking ADYNOVATE treatment according to the physician's decision will be included in this study.
Participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Participants who are newly prescribed with Adynovate and participants previously treated with Adynovate will be treated with ADYNOVATE for hemophilia A at the time of enrollment according to a regimen determined by the study site treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADYNOVATE | Biological | Pegylated recombinant human factor VIII |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Serious adverse events and non-serious adverse events | Throughout the duration of patient participation of up to approximately 6 months |
| Frequency of adverse events | Serious adverse events and non-serious adverse events | Throughout the duration of patient participation of up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inhibitor titers for FVIII antibodies | By titer levels, high and lower titer categories | Throughout the duration of patient participation of up to approximately 6 months |
| Number of treated bleeds |
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Inclusion Criteria
Participants with a diagnosis of hemophilia A who will be newly prescribed with ADYNOVATE or already have been prescribed ADYNOVATE according to the study physician's judgment shall be included in this study if:
Exclusion Criteria
Participants should be excluded from this study if:
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Hemophilia A participants in South Korea who will be newly prescribed with ADYNOVATE or already been prescribed with ADYNOVATE will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea | |||
| Kyungpook National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40680470 | Derived | Kim JY, Hwang T, Park SK, Yoo KY, Choi EJ, Kim S, You CW, Kim E, Jung A, Park YS. Real-world safety and effectiveness of rurioctocog alfa pegol in 338 patients with hemophilia A in South Korea: A postmarketing surveillance study. Thromb Res. 2025 Sep;253:109402. doi: 10.1016/j.thromres.2025.109402. Epub 2025 Jul 9. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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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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| ID | Term |
|---|---|
| C000609799 | BAX 855 |
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Number of treated bleeds throughout the study period
| Throughout the duration of patient participation of up to approximately 6 months |
| ADYNOVATE units required for bleed resolution | Number of ADYNOVATE units required for bleed resolution | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months |
| Number of ADYNOVATE infusions needed for the treatment of bleeding episodes | The number of ADYNOVATE infusions needed for each bleeding episode is determined by the participant, his/her caregiver, and/or clinician treating the participant, and is based upon the participant's response to treatment | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months |
| Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) | Throughout the duration of patient participation of up to approximately 6 months |
| Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months |
| Assessment of perioperative effectiveness of ADYNOVATE | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) | Throughout the duration of patient participation of up to approximately 6 months |
| Clinically significant changes in laboratory results | Number of clinically significant changes in laboratory results | Throughout the duration of patient participation of up to approximately 6 months |
| Daegu |
| 41944 |
| South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Kim Hugh Chul Internal Medicine | Seoul | 05538 | South Korea |
| Korea Hemophilia Foundation (Seoul) | Seoul | 06641 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |