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The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of children with hemophilia A. The study is open to pediatric patients in Canada who completed Baxter Study 060101.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM) | Drug | Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator). Once the treatment regimen was established, the regimen was to be maintained for the duration of the study, unless clinical reasons necessitated a change. The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences | Throughout the study period of approximately 23 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the hemostatic efficacy in the treatment of bleeding episodes; | At least 50 exposure days or a total treatment time of 6 months, whichever came first. | |
| assessment of the hemostatic efficacy in surgical or invasive procedures | From day of surgery until time of discharge from hospital or clinic (up to approximately 2 weeks post surgery). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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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 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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