Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Recruiting now
Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy
In brief
The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).
Key facts
- Study ID
- NCT04672733
- Run by
- CSL Behring
- People needed
- 100
- Starts
- 2022-06-10
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Concomitant participation in an interventional clinical study
Where it is running
- CH de Valence — Valence, France (enrolling)
- CHU Angers — Angers, France (enrolling)
- Hôpital privé de La Casamance — Aubagne, France (enrolling)
- CH Bayonne — Bayonne, France (enrolling)
- Hôpital Pellegrin — Bordeaux, France (enrolling)
- CHRU Brest — Brest, France (enrolling)
- Hôpital Henri Mondor — Créteil, France (enrolling)
- Hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
- CH Libourne — Libourne, France (enrolling)
- Hôpital Roger Salengro, CHU Lille — Lille, France (enrolling)
- Hôpital Dupuytren — Limoges, France (enrolling)
- Hôpital Pierre Wertheimer,HCL — Lyon, France (enrolling)
- Hôpital de la Timone — Marseille, France (enrolling)
- CHU Montpellier — Montpellier, France (enrolling)
- CHRU Nancy — Nancy, France (enrolling)
- CHU Nantes — Nantes, France (enrolling)
- Hôpital Pasteur — Nice, France (enrolling)
- Hôpital Lariboisière — Paris, France (enrolling)
- La Pitié-Salpêtrière — Paris, France (enrolling)
- CHU Poitiers — Poitiers, France (enrolling)
- Centre hospitalier privé Saint Grégoire — Rennes, France (enrolling)
- Hôpital Charles Nicolle — Rouen, France (enrolling)
- CHU Saint-Etienne — Saint-Etienne, France (enrolling)
- CHR Tours — Tours, France (enrolling)
- CHU Toulouse — Toulouse, France
Full record on ClinicalTrials.gov
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