Overview

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

Status:
Completed
Trial end date:
2006-11-10
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baxalta now part of Shire
Baxalta US Inc.
Treatments:
Factor VIII
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- Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the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