Status:
RECRUITING
Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Lead Sponsor:
CSL Behring
Conditions:
Chronic Inflammatory Demyelinating Polyneuropathy
Eligibility:
All Genders
18+ years
Brief 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 ever...
Detailed Description
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a neurological and rare type of autoimmune disorder. Intravenous immunoglobulin (IVIg) is the first-line treatment for CIDP which has been p...
Eligibility Criteria
Inclusion
- 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
- Concomitant participation in an interventional clinical study
Key Trial Info
Start Date :
June 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04672733
Start Date
June 10 2022
End Date
December 1 2027
Last Update
January 7 2025
Active Locations (27)
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1
CHU Amiens Picardie 1
Amiens, France, 80054
2
CHU Angers
Angers, France
3
Hôpital privé de La Casamance
Aubagne, France
4
CH Bayonne
Bayonne, France