Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases

To be part of this study, you need to be between 2 and 75 years old and have a clear diagnosis of primary immune deficiency. You must already be receiving regular immunoglobulin treatment for at least 12 weeks, whether it's given into a vein or under the skin, and your dose should have been steady during that time. Your current level of protective antibodies needs to be at a certain level.

There are some reasons why you might not be able to join. For example, if you've had a recent serious infection needing strong antibiotics or have certain other medical conditions. Also, if you have very specific types of immune deficiencies, like an isolated IgG subclass deficiency, or if you've had bad reactions to similar medicines containing IgA in the past, you wouldn't be able to participate.

If you decide to take part in this study, you'll be giving written permission (informed consent) to participate. You'll switch from your current immunoglobulin treatment to Newnorm, given under the skin. You'll need to attend several clinic visits for check-ups and to give blood samples so the researchers can monitor how the medicine is working and check for any side effects. You'll also be asked to follow the study plan carefully. The exact duration of the study, including follow-up, will be explained to you by the study team.