A multicenter, prospective, open label, historically controlled clinical trial to evaluate efficacy and safety in primary immunodeficiency diseases (PID) patients of Flebogamma® 5% DIF, the next generation of Flebogamma®

Background Flebogamma (R) 5% dual inactivation and filtration (DIF) is the next generation of Flebogamma (R). Flebogamma (R) was first licensed in 1992. The new preparation features additional viral inactivation and removal steps to enhance safety margins. Objective The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of Flebogamma (R) 5% DIF for immunoglobulin replacement therapy in primary immunodeficiency diseases (PID). Method Flebogamma (R) 5% DIF was administered at seven clinical sites to 46 subjects with well-defined primary immunodeficiency diseases at a dose of 300-600 mg/kg every 21-28 days for 12 months. Results The calculated serious bacterial infection rate was 0.021/subject/year. The incidence of adverse events considered potentially related to Flebogamma (R) 5% DIF during or within 72 h after completing an infusion was approximately 10%. The half-life in serum of the administered IgG was around 31 days. Conclusions Flebogamma (R) 5% DIF is efficacious and safe, has adequate pharmacokinetic properties, is well-tolerated and maintains the profile of Flebogamma (R) 5% for the treatment of primary humoral immunodeficiency diseases.