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

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemophilia A

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189982

060401

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Male

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

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• Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)