Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101

Study Overview
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Brief Summary
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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.

Official Title
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Recombinant Antihemophilic Factor Manufactured and Formulated Without Added Human or Animal Proteins (ADVATE rAHF-PFM): Safety Monitoring in Pediatric Patients Diagnosed With Severe to Moderately Severe Hemophilia A - A Continuation of Baxter Clinical Study 060101

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)


Participation Criteria
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Eligibility Criteria
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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or parent/legally authorized representative has provided written informed consent Exclusion Criteria: Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Factor VIII Deficiency