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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

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

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

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Victor Blanchette, MD, Principal Investigator, Affiliation: Hospital for Sick Children, Division of Hematology/Oncology, Toronto, Canada

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

assessment of the hemostatic efficacy in surgical or invasive procedures

Eligibility

Minimum age: N/A. Maximum age: 6 Years. Gender(s): Male.

Criteria:

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- Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the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 and Contacts

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information

Starting date: December 2004
Last updated: June 26, 2015

Page last updated: August 23, 2015

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