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
Study Design of a Phase 3, Open-Label Trial of the Safety and Efficacy of Recombinant Factor IX Fc Fusion Protein for the Prevention and Treatment of Bleeding Episodes in Previously Untreated Patients With Severe Hemophilia B
Gingival Bleeding and Oral Hygiene in Women with von Willebrand Disease
Objectives: To determine the relationship between von Willebrand disease (vWD), dental plaque, and gingival bleeding in women with vWD and to determine the oral hygiene habits and dental care utilization in women with vWD.…