This clinical trial is focused on studying Primary Immunodeficiency Diseases (PIDD), which are conditions where the immune system does not function properly, making it difficult for the body to fight infections. The study will evaluate a treatment called TAK-881, which is a solution for infusion containing human normal immunoglobulin and hyaluronidase (human recombinant). This treatment is compared to another medication known as HyQvia, which also contains human normal immunoglobulin. Both treatments are administered under the skin, a method known as subcutaneous administration.
The purpose of the study is to compare how the body processes these treatments and to assess their safety and tolerability in individuals aged 16 years and older with PIDD. Participants will receive both treatments at different times during the study. The study will monitor how the treatments are absorbed and used by the body, as well as any side effects that may occur. The study will also look at how often participants experience infections and how these affect their daily lives.
Participants will be involved in the study for a period of up to 27 weeks. During this time, they will receive regular infusions of the study medications and attend scheduled visits for monitoring. The study aims to provide valuable information on the effectiveness and safety of TAK-881 compared to HyQvia in managing Primary Immunodeficiency Diseases.
Czechia 
Denmark 
Germany 
Greece 
Poland 
Slovakia 
Spain 
The Netherlands