Evaluating Safety, Tolerability, and Efficacy of Subcutaneous Human Immunoglobulin 16.5% Administered at Modified Dosing Regimens in Patients with Primary Immunodeficiency Diseases – Study Design

Abstract

Immunoglobulin (Ig) concentrates have been successfully used to treat patients with primary immunodeficiency disorders (PID). Many patients opt to use subcutaneous route of administration (SCIg) for the convenience, flexibility and minimal systemic side effects. This study plans to evaluate safety, tolerability, and efficacy of a SCIg 16.5% at modified infusion regimens in adult and pediatric PID patients.