- 1.To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last.
- To compare pharmacokinetic (PK) parameters to ADVATE.
- 3. To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes.
- To evaluate safety and immunogenicity.
- To investigate changes in health-related quality of life (HRQoL) in pediatric subjects with severe hemophilia A.
1. To evaluate the PK parameters of BAX 855 in pediatric PTPs <12 years of age.
2. To monitor incremental recovery (IR) of BAX 855 over time.
3. To evaluate hemostatic efficacy of BAX 855 in the management of acute bleeding episodes and for prophylaxis over a period of 6 months.
4. To assess all AEs possibly or probably related to BAX 855.
5. To evaluate immunogenicity (binding antibodies to FVIII, BAX 855, PEG, and Chinese hamster ovary [CHO]) and clinically significant changes in routine laboratory parameters (hematology, clinical chemistry, and lipids) and vital signs.
6. To evaluate changes in HRQoL and health resource use.
Principal Investigator: Hassan Yaish
Department: Pediatric Administration