Hizentra® in Inflammatory Neuropathies - pHeNIx Study (pHeNIx)

January 6, 2025 updated by: CSL Behring
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU Amiens Picardie 1
      • Angers, France
        • Recruiting
        • CHU Angers
      • Aubagne, France
        • Recruiting
        • Hopital Privé de La Casamance
      • Bayonne, France
        • Recruiting
        • CH Bayonne
      • Bordeaux, France
        • Recruiting
        • Hôpital Pellegrin
      • Brest, France
        • Recruiting
        • CHRU Brest
      • Créteil, France
        • Recruiting
        • Hôpital Henri Mondor
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Hôpital Bicêtre
      • Libourne, France
        • Recruiting
        • CH Libourne
      • Lille, France
        • Recruiting
        • Hôpital Roger Salengro, CHU Lille
      • Limoges, France
        • Recruiting
        • Hopital Dupuytren
      • Lyon, France
        • Recruiting
        • Hôpital Pierre Wertheimer,HCL
      • Marseille, France
        • Recruiting
        • Hôpital de la timone
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
      • Nancy, France
        • Recruiting
        • CHRU Nancy
      • Nantes, France
        • Recruiting
        • CHU Nantes
      • Nice, France
        • Recruiting
        • Hopital Pasteur
      • Paris, France
        • Recruiting
        • Hôpital Lariboisiere
      • Paris, France
        • Recruiting
        • La Pitié-Salpétrière
      • Poitiers, France, 86000
        • Recruiting
        • Chu Poitiers
      • Rennes, France, 35760
        • Recruiting
        • Centre Hospitalier Privé Saint Grégoire
      • Rouen, France
        • Recruiting
        • Hôpital Charles Nicolle
      • Saint-Étienne, France
        • Recruiting
        • CHU Saint-étienne
      • Strasbourg, France, 67091
        • Not yet recruiting
        • CHU de Strasbourg
      • Toulouse, France
        • Not yet recruiting
        • CHU Toulouse
      • Tours, France
        • Recruiting
        • CHR Tours
      • Valence, France, 26000
        • Recruiting
        • CH de Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

French cohort of patients with CIDP

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Length of time of Continuation of treatment
Time Frame: up to 12 months

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®
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The time between the last dose of IVIg and starting Hizentra®
Time Frame: At Baseline
At Baseline
The total dose of the last course of IVIg
Time Frame: At Baseline
At Baseline
The interval between courses of IVIg
Time Frame: At Baseline
At Baseline
The total dose of the first course of Hizentra
Time Frame: At Baseline
At Baseline
The number of days of the first course of Hizentra
Time Frame: At Baseline
At Baseline
Number of Self-administrations or administrations by a state-registered nurse
Time Frame: Up to 12 months
Up to 12 months
The daily dose of Hizentra
Time Frame: Up to 12 months
Up to 12 months
The daily volume of Hizentra
Time Frame: Up to 12 months
Up to 12 months
Duration of the infusion
Time Frame: Up to 12 months
Up to 12 months
Number of infusion sites
Time Frame: Up to 12 months
Up to 12 months
Number of Patients completing the Patient Reported Outcome (PRO) tests at home
Time Frame: Up to 12 months
Up to 12 months
Rasch-built Overall Disability Scale (RODS) incapacity scale score by patient
Time Frame: Up to 12 months
Up to 12 months
10-metre walking test score by patient
Time Frame: Up to 12 months
Up to 12 months
Rasch-built Overall Disability Scale (RODS) incapacity scale score by doctor
Time Frame: Up to 12 months
Up to 12 months
10-metre walking test score by doctor
Time Frame: Up to 12 months
Up to 12 months
Time since the diagnosis of CIDP
Time Frame: At baseline
At baseline
EuroQol-5D (EQ-5D) quality of life score
Time Frame: Up to 12 months
Up to 12 months
Pictorial Representation of Illness and Self Measure (PRISM) score
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, CSL Behring SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pHeNIx study
  • 2019-A01803-54 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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