NCT04672733 Hizentra® in Inflammatory Neuropathies - pHeNIx Study
| NCT ID | NCT04672733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CSL Behring |
| Condition | Chronic Inflammatory Demyelinating Polyneuropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-06-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-06-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).
Eligibility Criteria
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
Contact & Investigator
Study Director
STUDY DIRECTOR
CSL Behring SA
Frequently Asked Questions
Who can join the NCT04672733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Inflammatory Demyelinating Polyneuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04672733 currently recruiting?
Yes, NCT04672733 is actively recruiting participants. Contact the research team at clinicaltrials@cslbehring.com for enrollment information.
Where is the NCT04672733 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Aubagne, France, Bayonne, France and 11 additional locations.
Who is sponsoring the NCT04672733 clinical trial?
NCT04672733 is sponsored by CSL Behring. The principal investigator is Study Director at CSL Behring SA. The trial plans to enroll 100 participants.