At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Prospective, Uncontrolled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity of BAX 855 (PEGylated Full-length Recombinant FVIII) in Previously Treated Pediatric Patients With Severe Hemophilia A
In Brief
A Phase 3 clinical trial evaluating Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method and PEGylated Recombinant Factor VIII for Hemophilia A. Completed, enrolled 75 participants across 39 sites in 11 countries.
Detailed Summary
The study purpose is: * 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. * To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes. * To evaluate safety and immunogenicity.
Study Details
Timeline
Interventions
Pharmacokinetic (PK) analysis of ADVATE
Pharmacokinetic (PK) analysis of BAX 855
Prophylaxis treatment