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| ID | Type | Description | Link |
|---|---|---|---|
| 2015/01011 | Other Identifier | Company Internal |
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The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY81-8973 | Hemophilia A patients who require Factor VIII replacement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973) | Drug | Treatment parameters following the physician's decision based on the summary of product characteristics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as measure of safety and tolerability | Up to 2 years | |
| Number of participants with serious adverse events as measure of safety and tolerability | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of annual bleeds | Up to 2 years | |
| Efficacy of controlling of bleeds | The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female hemophilia A patients are registered after the decision for treatment with Kovaltry has been made by the investigator. Both 'on demand' and 'prophylaxis' treatment are included.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Japan |
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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 |
|---|---|
| C078147 | F8 protein, human |
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011498 |
| Protein Precursors |
| D001685 | Biological Factors |