Hizentra® in Inflammatory Neuropathies - pHeNIx Study (pHeNIx)

April 18, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
      • Aubagne, France
        • Recruiting
        • Hôpital privé de La Casamance
      • Bayonne, France
        • Recruiting
        • CH Bayonne
      • Bordeaux, France
        • Recruiting
        • Hôpital Pellegrin
      • Brest, France
        • Recruiting
        • CHRU Brest
      • Créteil, France
        • Recruiting
        • Hopital 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
        • Hôpital 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
        • Hopital Lariboisiere
      • Paris, France
        • Recruiting
        • La Pitié-Salpêtrière
      • Poitiers, France, 86000
        • Recruiting
        • CHU Poitiers
      • Rennes, France, 35760
        • Not yet recruiting
        • Centre Hospitalier Privé Saint Grégoire
      • Rouen, France
        • Recruiting
        • Hopital Charles Nicolle
      • Saint-Étienne, France
        • Recruiting
        • CHU Saint-Etienne
      • 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

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

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

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

CSL Behring

Investigators

  • 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)

June 10, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Chronic Inflammatory Demyelinating Polyneuropathy

Clinical Trials on Hizentra

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe