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The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously Untreated Patients (PUPs) | PUPs in China with Moderate to Severe Hemophilia A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octocog alfa (recombinant human coagulation factor VIII) | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed | Throughout the study period of 6 months | |
| Number and type of other serious and non-serious adverse events (AEs) | Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors | Throughout the study period of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of bleeding episodes treated with ADVATE | Throughout the study period of 6 months | |
| Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE | Throughout the study period of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Oncology, Harbin The First Hospital | Harbin | Heilongjiang | 150070 | China | ||
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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| Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE | Throughout the study period of 6 months |
| Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE | Throughout the study period of 6 months |
| Total number of exposure days (EDs) to ADVATE | Throughout the study period of 6 months |
| Total units of ADVATE administered | Throughout the study period of 6 months |
| Total number of exposure days (EDs) to all Factor VIII (FVIII) products | Throughout the study period of 6 months |
| Total units of all Factor VIII (FVIII) products administered | Throughout the study period of 6 months |
| Henan Provincial People's Hospital |
| Zhengzhou |
| Henan |
| 450000 |
| China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | 430074 | China |
| Nanjing Children's Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | 210019 | China |
| Shandong Blood Center | Jinan | Shandong | 250014 | China |
| Zhejiang Provincial Hospital of TCM/The First Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | 310006 | China |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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 |
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| ID | Term |
|---|---|
| C078147 | F8 protein, human |
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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