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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-17

Study Completion Date

2006-11-10

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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

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