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Hizentra® in Inflammatory Neuropathies - pHeNIx Study (pHeNIx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04672733
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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).

Condition or disease Intervention/treatment
Chronic Inflammatory Demyelinating Polyneuropathy Biological: Hizentra

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Actual Study Start Date : June 10, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Biological: Hizentra
    Solution for injection for subcutaneous use
    Other Name: IgPro20

Outcome Measures
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Primary Outcome Measures :
  1. 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®


Secondary Outcome Measures :
  1. The time between the last dose of IVIg and starting Hizentra® [ Time Frame: At Baseline ]
  2. The total dose of the last course of IVIg [ Time Frame: At Baseline ]
  3. The interval between courses of IVIg [ Time Frame: At Baseline ]
  4. The total dose of the first course of Hizentra [ Time Frame: At Baseline ]
  5. The number of days of the first course of Hizentra [ Time Frame: At Baseline ]
  6. Number of Self-administrations or administrations by a state-registered nurse [ Time Frame: Up to 12 months ]
  7. The daily dose of Hizentra [ Time Frame: Up to 12 months ]
  8. The daily volume of Hizentra [ Time Frame: Up to 12 months ]
  9. Duration of the infusion [ Time Frame: Up to 12 months ]
  10. Number of infusion sites [ Time Frame: Up to 12 months ]
  11. Number of Patients completing the Patient Reported Outcome (PRO) tests at home [ Time Frame: Up to 12 months ]
  12. Rasch-built Overall Disability Scale (RODS) incapacity scale score by patient [ Time Frame: Up to 12 months ]
  13. 10-metre walking test score by patient [ Time Frame: Up to 12 months ]
  14. Rasch-built Overall Disability Scale (RODS) incapacity scale score by doctor [ Time Frame: Up to 12 months ]
  15. 10-metre walking test score by doctor [ Time Frame: Up to 12 months ]
  16. Time since the diagnosis of CIDP [ Time Frame: At baseline ]
  17. EuroQol-5D (EQ-5D) quality of life score [ Time Frame: Up to 12 months ]
  18. Pictorial Representation of Illness and Self Measure (PRISM) score [ Time Frame: Up to 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
French cohort of patients with CIDP
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672733


Contacts
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Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring SA
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04672733    
Other Study ID Numbers: pHeNIx study
2019-A01803-54 ( Other Identifier: ANSM )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CSL Behring:
CIDP
IgPro20
Hizentra
Subcutaneous Immunoglobulins
Additional relevant MeSH terms:
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Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes
Pathologic Processes