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
Phase 2
Completed
- Conditions
- Hemophilia A
- Registration Number
- NCT00189982
- Lead Sponsor
- Baxalta now part of Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4
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- Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences Throughout the study period of approximately 23 months.
- Secondary Outcome Measures
Name Time Method Assessment of the hemostatic efficacy in the treatment of bleeding episodes; 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 From day of surgery until time of discharge from hospital or clinic (up to approximately 2 weeks post surgery).
Trial Locations
- Locations (1)
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada