Hizentra® in Inflammatory Neuropathies - pHeNIx Study: Observing the Use and Effects of Subcutaneous Immunoglobulin in CIDP

What this Trial Is About

This research aims to understand how Hizentra®, a subcutaneous immunoglobulin treatment, is used in the care of adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a rare autoimmune neurological disorder. The study focuses on the process and effects of switching patients from intravenous immunoglobulin (IVIg) to subcutaneous immunoglobulin (SCIg) therapy, exploring real-life conditions, tolerability, and treatment effectiveness using patient-reported outcomes. This observational study is sponsored by CSL Behring and is conducted across multiple centers nationally. Participants will be monitored over a 36-month period, including a 24-month enrollment phase and a 12-month follow-up. Treatment involves switching from IVIg to Hizentra®, a subcutaneous injection solution, with no active intervention by researchers. The study tracks the timing, dosage, administration frequency, and methods of Hizentra® use in everyday practice, including self-administration or assistance by a nurse. During the study, participants will use a patient application to report outcomes related to treatment tolerance and efficacy. Researchers will collect data on disability scales, walking tests, quality of life scores, and medication dosing details at regular intervals throughout the 12-month follow-up. The main outcome measured is the length of time participants continue treatment with Hizentra®. Safety and treatment effects will be monitored without altering participants' usual care.

Hizentra® in Inflammatory Neuropathies - pHeNIx Study