NCT04672733Recruiting
Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 11 Dec 2020
- Start date
- 10 Jun 2022
- Primary completion date
- Dec 2027
- Lead sponsor
- CSL Behring
- NCT number
- NCT04672733
What you commit to
- Study type: Observational
- Planned participants: 100
- From 10 Jun 2022 to the primary completion date, Dec 2027
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant participation in an interventional clinical study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.