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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | CSL Behring Industry-sponsored |
| Locations | 27 sites (Amiens and 26 other locations) |
| Status | Recruiting |
| Started | June 10, 2022 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT04672733 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
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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
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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
- Study coordinator: Trial Registration Coordinator
- Email: clinicaltrials@cslbehring.com
- Phone: +1 610-878-4697
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
-
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.
-
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.
-
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.