Using Hizentra® for treating Chronic Inflammatory Demyelinating Polyneuropathy

Hizentra® in Inflammatory Neuropathies - pHeNIx Study

Observational CSL Behring · NCT04672733

This study is testing how well Hizentra® works for people with Chronic Inflammatory Demyelinating Polyneuropathy when switching from an IV treatment to a shot under the skin.

Quick facts

Study typeObservational
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorCSL Behring Industry-sponsored
Locations27 sites (Amiens and 26 other locations)
Trial IDNCT04672733 on ClinicalTrials.gov

What this trial studies

The pHeNIx study is a national multicentre observational study aimed at understanding the use of Hizentra® in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It focuses on the transition from intravenous immunoglobulin (IVIg) to subcutaneous immunoglobulin (SCIg) treatment, assessing tolerability and efficacy through patient-reported outcomes. The study seeks to gather real-world data on the characteristics of patients receiving this treatment and the methods for switching routes of administration.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have been diagnosed with CIDP and are planning to switch from IVIg to Hizentra®.

Not a fit: Patients currently participating in another interventional clinical study may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into a more stable and convenient treatment option for patients with CIDP.

How similar studies have performed: Previous studies have shown promise in using subcutaneous immunoglobulins for CIDP, but this study aims to provide more comprehensive real-world data.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patient (aged ≥18 years)
* Patients suffering from CIDP according to EAN/PNS 2021 criteria
* Planned switch from IVIg to Hizentra®
* Patient treated with at least 3 courses of IV immunoglobulin and deemed by the investigator to be dependent on immunoglobulins
* Patient deemed to be stable, with no change in their treatment for the disease during the 3 months prior to inclusion
* Patients who have a smartphone, a tablet or a computer
* Patients who have been informed verbally and in writing of the purposes of the study

Exclusion Criteria:

* Concomitant participation in an interventional clinical study

Where this trial is running

Amiens and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Chronic Inflammatory Demyelinating PolyneuropathyCIDPIgPro20HizentraSubcutaneous Immunoglobulins
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.