A clinical trial protocol to evaluate the safety and pharmacokinetics of subcutaneously administered immunoglobulin in patients with primary immunodeficiency

Abstract

This protocol is excerpted from recent clinical trials used to study the pharmacokinetics, safety, and tolerability of subcutaneously administered immunoglobulin (SCIG) in subjects with primary immunodeficiency. The primary objective is to determine the weekly dose of SCIG product that produces a steady-state area under the concentration-time curve of total immunoglobulin G level that is non-inferior to that of regularly administered intravenous immunoglobulin (IVIG). We include details of the target population, eligibility criteria, treatment phases, key assessments and procedures, and study analyses. Given that IVIG may be problematic in patients with poor venous access or those who develop systemic adverse effects, among others, the development of SCIG for use in the home setting provides an alternative treatment technique for adults and children with primary immunodeficiency. Statement of novelty: This protocol describes the main topics found in prospective clinical studies evaluating the safety and pharmacokinetics of SCIG in subjects with primary immunodeficiency.