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Chronic Inflammatory Demyelinating PolyneuropathypHeNIxNCT04672733

Hizentra® in Inflammatory Neuropathies - pHeNIx Study

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by CSL Behring at 27 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hizentra
Type of treatment
Injection or infusion
How many people
100 participants
Where
27 sitesFrance
Study dates
10 Jun 2022to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: French cohort of patients with CIDP

Who may be able to join

  • 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

Who cannot join

  • Concomitant participation in an interventional clinical study

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Trial Registration Coordinator contact

+1 610-878-4697

clinicaltrials@cslbehring.com

27 sites in 1 country

France27 sites, 27 recruiting

  • CHU Amiens Picardie 1

    Amiens, 80054

    Not yet recruiting

  • CHU Angers

    Angers

    Recruiting

  • Hôpital privé de La Casamance

    Aubagne

    Recruiting

  • CH Bayonne

    Bayonne

    Recruiting

  • Hôpital Pellegrin

    Bordeaux

    Recruiting

  • CHRU Brest

    Brest

    Recruiting

  • Hôpital Henri Mondor

    Créteil

    Recruiting

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

    Recruiting

  • CH Libourne

    Libourne

    Recruiting

  • Hôpital Roger Salengro, CHU Lille

    Lille

    Recruiting

  • Hôpital Dupuytren

    Limoges

    Recruiting

  • Hôpital Pierre Wertheimer,HCL

    Lyon

    Recruiting

  • Hôpital de la Timone

    Marseille

    Recruiting

  • CHU Montpellier

    Montpellier

    Recruiting

  • CHRU Nancy

    Nancy

    Recruiting

  • CHU Nantes

    Nantes

    Recruiting

  • Hôpital Pasteur

    Nice

    Recruiting

  • Hôpital Lariboisière

    Paris

    Recruiting

  • La Pitié-Salpêtrière

    Paris

    Recruiting

  • CHU Poitiers

    Poitiers, 86000

    Recruiting

  • Centre hospitalier privé Saint Grégoire

    Rennes, 35760

    Recruiting

  • Hôpital Charles Nicolle

    Rouen

    Recruiting

  • CHU Saint-Etienne

    Saint-Etienne

    Recruiting

  • CHU de Strasbourg

    Strasbourg, 67091

    Not yet recruiting

  • CHU Toulouse

    Toulouse

    Not yet recruiting

  • CHR Tours

    Tours

    Recruiting

  • CH de Valence

    Valence, 26000

    Recruiting

Other trials in France

About this study

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).

Read the 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 proven to be effective. For several years, published cases have suggested that the Sub-Cutaneous Ig (SCIg) may be an alternative treatment to IVIg in the treatment of CIDP. Compared to IVIg treatment, the SCIg can achieve more stable plasma IgG concentrations, suggesting a potential reduction in the dose exhaustion effect at the end of the cycle, but also fewer systemic effects. SC administration also enables more straightforward treatment to be given for ambulatory patients.

Based on the PATH study (NCT01545076), a double blind placebo-controlled, randomised, prospective, international multicentre phase III study, Hizentra® obtained an extension of its marketing authorization for the CIDP indication as maintenance treatment after stabilisation with IVIg.

However, in the "real-life" situation, the literature is still based at present on small series of patient or short-term follow-up periods.

However, the methods for switching from the IV to the SC route and the characteristics of patients receiving this treatment are not known. In addition, SCIg administration remote from a specialist centre without assistance from a health professional no longer enables a more regular assessment of the patient in terms of tolerability and efficacy.

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). The study duration is estimated to be 36 months in view of: a 24-month inclusion period and a 12-month follow-up period.

Being tested
Hizentra
Keywords
CIDP, IgPro20, Hizentra, Subcutaneous Immunoglobulins
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HizentraBiological

    Also called IgPro20

    Solution for injection for subcutaneous use

What is being measured

The primary outcome is the main question the study is designed to answer.

  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®

    Measured: up to 12 months

Secondary outcomes (18)

  1. The time between the last dose of IVIg and starting Hizentra®

    Measured: At Baseline

  2. The total dose of the last course of IVIg

    Measured: At Baseline

  3. The interval between courses of IVIg

    Measured: At Baseline

  4. The total dose of the first course of Hizentra

    Measured: At Baseline

  5. The number of days of the first course of Hizentra

    Measured: At Baseline

  6. Number of Self-administrations or administrations by a state-registered nurse

    Measured: Up to 12 months

  7. The daily dose of Hizentra

    Measured: Up to 12 months

  8. The daily volume of Hizentra

    Measured: Up to 12 months

  9. Duration of the infusion

    Measured: Up to 12 months

  10. Number of infusion sites

    Measured: Up to 12 months

  11. Number of Patients completing the Patient Reported Outcome (PRO) tests at home

    Measured: Up to 12 months

  12. Rasch-built Overall Disability Scale (RODS) incapacity scale score by patient

    Measured: Up to 12 months

  13. 10-metre walking test score by patient

    Measured: Up to 12 months

  14. Rasch-built Overall Disability Scale (RODS) incapacity scale score by doctor

    Measured: Up to 12 months

  15. 10-metre walking test score by doctor

    Measured: Up to 12 months

  16. Time since the diagnosis of CIDP

    Measured: At baseline

  17. EuroQol-5D (EQ-5D) quality of life score

    Measured: Up to 12 months

  18. Pictorial Representation of Illness and Self Measure (PRISM) score

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start10 Jun 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04672733
Sponsor's protocol ID
pHeNIx study
Other IDs
2019-A01803-54
Acronym
pHeNIx
Status last verified
Jan 2025
First submitted
11 Dec 2020
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by CSL Behring at 27 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Registration Coordinator (+1 610-878-4697, clinicaltrials@cslbehring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of time of Continuation of treatment (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04672733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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