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

Baxalta now part of Shire4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemophilia A

Interventions

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.

Eligibility

Sex: MALEMax age: 6 Years

Medical Language ↔ Plain English

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parent/legally authorized representative has provided written informed consent Exclusion Criteria: * Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study

Locations (1)

Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences

Time frame: Throughout the study period of approximately 23 months.

Secondary Outcomes

Assessment of the hemostatic efficacy in the treatment of bleeding episodes;

Time frame: 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

Time frame: From day of surgery until time of discharge from hospital or clinic (up to approximately 2 weeks post surgery).

Data from ClinicalTrials.gov

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