Hizentra® in Inflammatory Neuropathies – pHeNIx Study

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Brief Title

Hizentra® in Inflammatory Neuropathies - pHeNIx Study

Official Title

Hizentra® in Inflammatory Neuropathies - pHeNIx Study

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).
    

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


Primary Outcome

Length of time of Continuation of treatment

Secondary Outcome

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

Condition

Chronic Inflammatory Demyelinating Polyneuropathy

Intervention

Hizentra


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

100

Start Date

March 2022

Completion Date

September 2024

Primary Completion Date

September 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patient (aged ≥18 years)

          -  Patients suffering from CIDP according to EFNS/PNS 2010 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 smart phone, 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Study Director, 610-878-4000, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04672733

Organization ID

pHeNIx study

Secondary IDs

2019-A01803-54

Responsible Party

Sponsor

Study Sponsor

CSL Behring


Study Sponsor

Study Director, Study Director, CSL Behring SA


Verification Date

April 2021