Hizentra in Inflammatory Neuropathies: Observational Study on Switching from Intravenous to Subcutaneous Treatment and Monitoring in CIDP

What this Trial Is About

Researchers are studying the use of Hizentra®, a subcutaneous immunoglobulin treatment, in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a rare autoimmune neurological disorder. The study aims to understand how patients switch from intravenous immunoglobulin (IVIg) treatments to subcutaneous immunoglobulin (SCIg) like Hizentra® in real-life settings. The study also evaluates the tolerability and effectiveness of Hizentra® using patient-reported outcomes collected through a mobile application. This is a national, prospective, non-interventional study conducted over an estimated 36 months, including a 24-month enrollment period and a 12-month follow-up. Participants will receive Hizentra®, which is administered as a subcutaneous injection solution. The study focuses on patients who are planned to switch from IVIg to Hizentra® and have been stable on their treatment for at least three months. The approach allows for treatment to be administered outside of specialist centers. Researchers will observe and document how patients use Hizentra® in everyday practice without changing the usual care. No additional experimental treatments are given as this is a non-interventional study. During the study, participants will use a patient application to report on their treatment experience, including tolerability and efficacy. The main outcome measured is the length of time the treatment continues, up to 12 months. The study monitors patient health and treatment adherence during this period to provide real-world data on Hizentra® use. Participants must have access to a smartphone, tablet, or computer to use the application. Overall, the study aims to gather comprehensive information about switching treatments and managing CIDP with Hizentra® in daily life.

Hizentra® in Inflammatory Neuropathies - pHeNIx Study