Approval Probability
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ML Risk
Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Subject must have participated and completed participation in Baxter's clinical study 060101 * Subject or parent/legally authorized representative has provided written informed consent Exclusion Criteria: * Subjects who have withdrawn from Baxter's Clinical Study 060101 prio...