This clinical trial is focused on studying a group of diseases known as primary immunodeficiency diseases (PID). These are conditions where the immune system does not function properly, making it difficult for the body to fight off infections. The treatment being tested in this study is called Newnorm, which is a form of human normal immunoglobulin. This is a solution that is given through an infusion under the skin, known as subcutaneous administration. The purpose of the study is to evaluate how well Newnorm works in preventing serious bacterial infections in patients with PID.
Participants in the study will receive Newnorm once a week. The study aims to ensure that this weekly treatment maintains levels of a protein called immunoglobulin G (IgG) in the blood, which helps protect against infections, at levels similar to those achieved with less frequent treatments. The study will last for about a year, during which the safety and effectiveness of Newnorm will be closely monitored. Researchers will look at how often serious infections occur, how quickly infections resolve, and other factors like the use of antibiotics and hospital visits due to infections.
Throughout the study, participants will be asked to provide information about their health and any infections they experience. This will help researchers understand the impact of Newnorm on their quality of life, including time lost from work or school due to illness. The study is designed to gather important information that could lead to better treatment options for people with primary immunodeficiency diseases.



Germany
Hungary
Italy
Poland
Slovakia