Brief Title
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
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
Brief 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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
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;
Condition
Hemophilia A
Intervention
Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
4
Start Date
December 17, 2004
Completion Date
November 10, 2006
Primary Completion Date
November 10, 2006
Eligibility 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parent/legally authorized representative has provided written informed consent Exclusion Criteria: - Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study
Gender
Male
Ages
N/A - 6 Years
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00189982
Organization ID
060401
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
May 2021