Hizentra® in Inflammatory Neuropathies - pHeNIx Study

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

— pHeNIx  

Official title:

Hizentra® in Inflammatory Neuropathies - pHeNIx Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672733
• Other study ID #: pHeNIx study
• Secondary ID: 2019-A01803-54
• Status: Recruiting
• Start date: June 10, 2022
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: CSL Behring
• Contact: Trial Registration Coordinator
• Phone: 610-878-4000
• Email: clinicaltrials[@]cslbehring.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (PRO: Patient-Reported Outcomes).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Biological:
• Hizentra
Solution for injection for subcutaneous use

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpital privé de La Casamance	Aubagne
France	CH Bayonne	Bayonne
France	Hôpital Pellegrin	Bordeaux
France	CHRU Brest	Brest
France	Hôpital Henri Mondor	Créteil
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	CH Libourne	Libourne
France	Hôpital Roger Salengro, CHU Lille	Lille
France	Hôpital Dupuytren	Limoges
France	Hôpital Pierre Wertheimer,HCL	Lyon
France	Hôpital de la Timone	Marseille
France	CHU Montpellier	Montpellier
France	CHRU Nancy	Nancy
France	CHU Nantes	Nantes
France	Hôpital Pasteur	Nice
France	Hôpital Lariboisière	Paris
France	La Pitié-Salpêtrière	Paris
France	CHU Poitiers	Poitiers
France	Centre hospitalier privé Saint Grégoire	Rennes
France	Hôpital Charles Nicolle	Rouen
France	CHU Saint-Etienne	Saint-Étienne
France	CHU de Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CHR Tours	Tours
France	CH de Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®	up to 12 months
Secondary	The time between the last dose of IVIg and starting Hizentra®		At Baseline
Secondary	The total dose of the last course of IVIg		At Baseline
Secondary	The interval between courses of IVIg		At Baseline
Secondary	The total dose of the first course of Hizentra		At Baseline
Secondary	The number of days of the first course of Hizentra		At Baseline
Secondary	Number of Self-administrations or administrations by a state-registered nurse		Up to 12 months
Secondary	The daily dose of Hizentra		Up to 12 months
Secondary	The daily volume of Hizentra		Up to 12 months
Secondary	Duration of the infusion		Up to 12 months
Secondary	Number of infusion sites		Up to 12 months
Secondary	Number of Patients completing the Patient Reported Outcome (PRO) tests at home		Up to 12 months
Secondary	Rasch-built Overall Disability Scale (RODS) incapacity scale score by patient		Up to 12 months
Secondary	10-metre walking test score by patient		Up to 12 months
Secondary	Rasch-built Overall Disability Scale (RODS) incapacity scale score by doctor		Up to 12 months
Secondary	10-metre walking test score by doctor		Up to 12 months
Secondary	Time since the diagnosis of CIDP		At baseline
Secondary	EuroQol-5D (EQ-5D) quality of life score		Up to 12 months
Secondary	Pictorial Representation of Illness and Self Measure (PRISM) score		Up to 12 months