Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCSL Behring
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Concomitant participation in an interventional clinical study
Trial population
French cohort of patients with CIDP
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hizentra
Biological/VaccineSolution for injection for subcutaneous use
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Length of time of Continuation of treatment
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®
Time frame
up to 12 monthsSecondary outcomes
1
The time between the last dose of IVIg and starting Hizentra®
Time frame
At Baseline2
The total dose of the last course of IVIg
Time frame
At Baseline3
The interval between courses of IVIg
Time frame
At Baseline4
The total dose of the first course of Hizentra
Time frame
At BaselineSponsors and contacts
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Source ClinicalTrials.gov