NCT04672733

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

27 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jun 2022Dec 2027

First Submitted

Initial submission to the registry

December 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

5.5 years

First QC Date

December 11, 2020

Last Update Submit

January 6, 2025

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

CIDPIgPro20HizentraSubcutaneous Immunoglobulins

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

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

    At Baseline

  • The total dose of the last course of IVIg

    At Baseline

  • The interval between courses of IVIg

    At Baseline

  • The total dose of the first course of Hizentra

    At Baseline

  • The number of days of the first course of Hizentra

    At Baseline

  • +13 more secondary outcomes

Interventions

HizentraBIOLOGICAL

Solution for injection for subcutaneous use

Also known as: IgPro20

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

French cohort of patients with CIDP

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Concomitant participation in an interventional clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

CHU Amiens Picardie 1

Amiens, 80054, France

NOT YET RECRUITING

CHU Angers

Angers, France

RECRUITING

Hôpital privé de La Casamance

Aubagne, France

RECRUITING

CH Bayonne

Bayonne, France

RECRUITING

Hôpital Pellegrin

Bordeaux, France

RECRUITING

CHRU Brest

Brest, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

RECRUITING

CH Libourne

Libourne, France

RECRUITING

Hôpital Roger Salengro, CHU Lille

Lille, France

RECRUITING

Hôpital Dupuytren

Limoges, France

RECRUITING

Hôpital Pierre Wertheimer,HCL

Lyon, France

RECRUITING

Hôpital de la Timone

Marseille, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHRU Nancy

Nancy, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Hôpital Pasteur

Nice, France

RECRUITING

Hôpital Lariboisière

Paris, France

RECRUITING

La Pitié-Salpêtrière

Paris, France

RECRUITING

CHU Poitiers

Poitiers, 86000, France

RECRUITING

Centre hospitalier privé Saint Grégoire

Rennes, 35760, France

RECRUITING

Hôpital Charles Nicolle

Rouen, France

RECRUITING

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

CHU de Strasbourg

Strasbourg, 67091, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, France

NOT YET RECRUITING

CHR Tours

Tours, France

RECRUITING

CH de Valence

Valence, 26000, France

RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Hizentra

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Study Director

    CSL Behring SA

    STUDY DIRECTOR

Central Study Contacts

Trial Registration Coordinator

CONTACT

+1 610-878-4697clinicaltrials@cslbehring.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 17, 2020

Study Start

June 10, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

FR(27)