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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parent/legally authorized representative has provided written informed consent Exclusion Criteria: * Subjects who have withdrawn from Baxter's Clinical Study 060101 prio...
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It is used for the treatment of Hemophilia A, a bleeding disorder caused by deficient or missing factor VIII. The product is a recombinant factor VIII therapy developed to replace the missing clotting protein in patients with this condition. It was studied in pediatric patients in Canada.
It targets factor VIII, also known as F8, the clotting protein that is deficient or dysfunctional in Hemophilia A. The product is an exogenous protein designed to supply functional factor VIII. Its target class is an exogenous protein rather than a small molecule acting on a receptor.
Takeda Pharmaceutical Company Limited develops this recombinant factor VIII product. Takeda trades on the New York Stock Exchange under the ticker TAK. The pediatric Hemophilia A study was described as a continuation of an earlier Baxter study, reflecting the program's history within the Baxter hemophilia portfolio.
It is in Phase 2 development. The only registered trial for this product was a Phase 2 study, and it has been completed. The product is investigational and is not described as approved for any indication.
One trial is registered: NCT00189982, titled Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A. It was a Phase 2, completed, uncontrolled study in Canada that enrolled four male pediatric patients. No other trials are listed.
Yes. rAHF-PFM is the abbreviated name for Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins. The abbreviation stands for recombinant antihemophilic factor, plasma protein free, and refers to the same recombinant factor VIII product studied in pediatric Hemophilia A patients.