Clinical trial Recruiting at 24 sites Observational Ages 18 and up

Using Hizentra® for treating Chronic Inflammatory Demyelinating Polyneuropathy

Official title: Hizentra® in Inflammatory Neuropathies - pHeNIx Study

Run by CSL Behring · NCT04672733 · Data updated 2026-11-12

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
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorCSL Behring
Industry-sponsored
Locations27 sites (Amiens and 26 other locations)
StatusRecruiting
StartedJune 10, 2022
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedJanuary 7, 2025
Trial IDNCT04672733 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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®.

Probably not a fit

Patients currently participating in another interventional clinical study may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

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 it's running

  • CHU Angers
    Angers, France
    Recruiting
  • Hôpital privé de La Casamance
    Aubagne, France
    Recruiting
  • CH Bayonne
    Bayonne, France
    Recruiting
  • Hôpital Pellegrin
    Bordeaux, France
    Recruiting
  • CHRU Brest
    Brest, France
    Recruiting
  • Hôpital Henri Mondor
    Créteil, France
    Recruiting
Show 21 more locations
  • Hôpital Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CH Libourne
    Libourne, France
    Recruiting
  • Hôpital Roger Salengro, CHU Lille
    Lille, France
    Recruiting
  • Hôpital Dupuytren
    Limoges, France
    Recruiting
  • Hôpital Pierre Wertheimer,HCL
    Lyon, France
    Recruiting
  • Hôpital de la Timone
    Marseille, France
    Recruiting
  • CHU Montpellier
    Montpellier, France
    Recruiting
  • CHRU Nancy
    Nancy, France
    Recruiting
  • CHU Nantes
    Nantes, France
    Recruiting
  • Hôpital Pasteur
    Nice, France
    Recruiting
  • Hôpital Lariboisière
    Paris, France
    Recruiting
  • La Pitié-Salpêtrière
    Paris, France
    Recruiting
  • CHU Poitiers
    Poitiers, France
    Recruiting
  • Centre hospitalier privé Saint Grégoire
    Rennes, France
    Recruiting
  • Hôpital Charles Nicolle
    Rouen, France
    Recruiting
  • CHU Saint-Etienne
    Saint-Etienne, France
    Recruiting
  • CHR Tours
    Tours, France
    Recruiting
  • CH de Valence
    Valence, France
    Recruiting
  • CHU Amiens Picardie 1
    Amiens, France
    Not yet recruiting
  • CHU de Strasbourg
    Strasbourg, France
    Not yet recruiting
  • CHU Toulouse
    Toulouse, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • KITE-363 treatment for relapsed or refractory autoimmune neurologic diseases

    This study will test whether KITE-363 is safe and can help people with relapsed or treatment-resistant autoimmune neurologic diseases such as MS, CIDP, and myasthenia gravis.

    Recruiting at 10 sites Phase 1 Gilead Sciences · Newport Beach, California and 9 other locations · NCT07304154

  • Immunoadsorption treatment for chronic inflammatory demyelinating polyneuropathy

    This observational study will try immunoadsorption as a next-step treatment for adults with CIDP who do not respond well to IVIg or methylprednisolone.

    Recruiting University of Ulm · Ulm, Baden-Wurttemberg · NCT07154524

  • Empasiprubart for adults with CIDP

    This study will test whether IV empasiprubart helps improve symptoms and is safe for adults with CIDP, with an initial 24-week randomized comparison to placebo followed by two years of empasiprubart for all participants.

    Recruiting at 94 sites Phase 3 argenx · Birmingham, Alabama and 93 other locations · NCT07091630

  • Imeroprubart for adults with CIDP

    This study will test whether the monoclonal antibody Imeroprubart helps adults with active CIDP who are already on stable immunoglobulin or corticosteroid treatment.

    Recruiting at 117 sites Phase 2 Immunovant Sciences GmbH · Tucson, Arizona and 141 other locations · NCT07032662

  • Empasiprubart versus IVIg for treating CIDP in adults

    This trial tests whether empasiprubart works as well as IVIg and is safe for adults with CIDP who currently benefit from IVIg.

    Recruiting at 107 sites Phase 3 argenx · Birmingham, Alabama and 106 other locations · NCT06920004

  • Evaluating DNTH103 for treating chronic inflammatory demyelinating polyneuropathy

    This study is testing a new treatment called DNTH103 to see if it can help adults with chronic inflammatory demyelinating polyneuropathy feel better and stay safe.

    Recruiting at 201 sites Phase 3 Dianthus Therapeutics · Birmingham, Alabama and 200 other locations · NCT06858579

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.