Joint Outcomes by Magnetic Resonance Imaging After Treatment With Bayer’s Sucrose-Formulated Recombinant Factor VIII in the SPINART Study: Results at the 3-year Evaluation Timepoint
Objective: Joint status was assessed in the 3-year SPINART study, which compared routine prophylaxis versus on-demand treatment in adults with severe hemophilia A. We report joint outcomes at year 3 obtained using magnetic…
SPINART Trial 3-Year Results With Bayer’s Sucrose-Formulated Recombinant Factor VIII: Improved Joint Function and Health-Related Quality of Life in Adults Using Prophylaxis
Objective: Joint status and health-related quality of life (HRQoL) were assessed as part of the 3-year SPINART study, which compared routine prophylaxis versus on-demand treatment in adults with severe hemophilia A. We report…
Production and Characterization of BAX 855, PEGylated rFVIII with Extended Half-Life
Objective: Baxter has developed BAX 855, a PEGylated form of Baxter’s recombinant full length FVIII (rFVIII) product based on the ADVATETM manufacturing process. Here we describe it ́s manufacturing and structural and functional…
3-Year Results From SPINART: Prolonged Reduction of Bleeding With Prophylaxis Using Bayer’s Sucrose-Formulated Recombinant Factor VIII
Objective: In the 3-year SPINART study, routine prophylaxis and on-demand treatment were compared in adults with severe hemophilia A. We report final SPINART efficacy and safety results after 3 study years. Methods:…
Dosing Routines and Bleeding Rates Before and Following Treatment with rFVIIIFc in the A-LONG Clinical Study
A Prospective Case-Control Study of Bleeding Phenotype in Hemophilia A Carriers
Extended-interval Dosing with rFIXFc Is Associated With Low Bleeding Rates and a Reduction in Weekly Factor Use
Safety of BAX 855, a Polyethylene Glycol (PEG) Conjugated Full-Length Recombinant Factor VIII Product
Objectives: Biopharmaceuticals are an emerging branch of therapeutic agents. Their short half-life, rapid elimination and ability to induce a specific immune response, however, may impair their applicability. These disadvantages…
A Study Evaluating the Impact of myCubixx, an Innovative Factor Inventory Management and Storage System with Selected Outcomes on People with Hemophilia A
Study Design of a Phase 3, Open-Label Trial of the Safety and Efficacy of Recombinant Factor VIII Fc Fusion Protein for the Prevention and Treatment of Bleeding Episodes in Previously Untreated Patients With Severe Hemophilia A