Using Hizentra® for treating Chronic Inflammatory Demyelinating Polyneuropathy
Hizentra® in Inflammatory Neuropathies - pHeNIx Study
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CSL Behring Industry-sponsored |
| Locations | 27 sites (Amiens and 26 other locations) |
| Trial ID | NCT04672733 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
- CHU Amiens Picardie 1 — Amiens, France (Not_yet_recruiting)
- 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)
- 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)
- CHU de Strasbourg — Strasbourg, France (Not_yet_recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- CHR Tours — Tours, France (Recruiting)
- CH de Valence — Valence, France (Recruiting)
Study contacts
- Study coordinator: Trial Registration Coordinator
- Email: clinicaltrials@cslbehring.com
- Phone: +1 610-878-4697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.