RecruitingNCT04672733

Hizentra® in Inflammatory Neuropathies - pHeNIx Study


Sponsor

CSL Behring

Enrollment

100 participants

Start Date

Jun 10, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria1

  • Concomitant participation in an interventional clinical study

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Interventions

BIOLOGICALHizentra

Solution for injection for subcutaneous use


Locations(27)

CHU Amiens Picardie 1

Amiens, France

CHU Angers

Angers, France

Hôpital privé de La Casamance

Aubagne, France

CH Bayonne

Bayonne, France

Hôpital Pellegrin

Bordeaux, France

CHRU Brest

Brest, France

Hôpital Henri Mondor

Créteil, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

CH Libourne

Libourne, France

Hôpital Roger Salengro, CHU Lille

Lille, France

Hôpital Dupuytren

Limoges, France

Hôpital Pierre Wertheimer,HCL

Lyon, France

Hôpital de la Timone

Marseille, France

CHU Montpellier

Montpellier, France

CHRU Nancy

Nancy, France

CHU Nantes

Nantes, France

Hôpital Pasteur

Nice, France

Hôpital Lariboisière

Paris, France

La Pitié-Salpêtrière

Paris, France

CHU Poitiers

Poitiers, France

Centre hospitalier privé Saint Grégoire

Rennes, France

Hôpital Charles Nicolle

Rouen, France

CHU Saint-Etienne

Saint-Etienne, France

CHU de Strasbourg

Strasbourg, France

CHU Toulouse

Toulouse, France

CHR Tours

Tours, France

CH de Valence

Valence, France

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NCT04672733


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