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Clinical Trials in France / NCT04672733
Recruiting Observational

Hizentra® in Inflammatory Neuropathies - pHeNIx Study

NCT04672733 · tracked via the Priya Life Science France tracker
Sponsor
CSL Behring
Phase
Observational
Started
2022-06-10
Last updated
2025-01-07

Condition(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy

Investigational drug(s) / intervention(s)

Hizentra →

Hizentra: Solution for injection for subcutaneous use

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Length of time of Continuation of treatment — up to 12 months
    Non-continuation is defined by: * an increase in the INCAT score of over one point measured in a consultation despite a bolus dose of IVIg and/or after increasing the dose of Hizentra® * stopping treatment with Hizentra®

Trial sites (27)

FacilityCityRegionStatus
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

More CSL Behring trials in France

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Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis Recruiting
Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B Recruiting
Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies Recruiting

Other trials for the same condition

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP Recruiting
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP Recruiting
A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04672733 on ClinicalTrials.gov ↗ ← All trials in France