NCT00189982

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: Male
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)	Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator). Once the treatment regimen was established, the regimen was to be maintained for the duration of the study, unless clinical reasons necessitated a change. The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care.

Timeline

• Start date: 2004-12-17
• Primary completion: 2006-11-10
• Completion: 2006-11-10
• First posted: 2005-09-19
• Last updated: 2021-05-05

Locations

1 site across 1 country: Canada