Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP (HELIPAD 1)

January 13, 2021 updated by: CSL Behring

A Multicenter Pilot Study to Determine Criteria for Evaluating the Effectiveness of Two Comparative Monitoring Methods in the Management of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Receiving Home-based Treatment With IVIg (Privigen®)

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course.

Diagnosis is based on clinical presentation and electrophysiological findings in accordance with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown to be effective in several placebo-controlled trials.

Once IVIg therapy produces a response and is well tolerated, some patients are able to continue their treatment in the home setting. The HOME LINK system offers an integrated, global solution based on telemonitoring technology providing continuous, remote monitoring of Privigen® infusions administered at home.

Study Overview

Status

Terminated

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Intervention / Treatment

Device: HOME LINK

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Bordeaux, France
    - Hôpital Pellegrin, Bordeaux University Hospital (CHU)
  - Créteil, France
    - Hôpital Henri Mondor - APHP
  - Lille, France
    - Hôpital Roger Salengro - CHRU
  - Lyon, France
    - Hopital Pierre Wertheimer - HCL
  - Marseille, France
    - Hôpital La Timone - APHM
  - Montpellier, France
    - Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)
  - Nice, France
    - Hôpital Pasteur 2 - Nice University Hospital (CHU)
  - Paris, France
    - Hôpital La Pitié-Salpêtrière - APHP
  - Paris, France
    - Hôpital Lariboisière - APHP
  - Saint Etienne, France
    - Hôpital Nord - Saint Etienne University Hospital (CHU)

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving home-based IVIg therapy with Privigen

Description

Inclusion Criteria:

Patient with a diagnosis of CIDP as per EFNS/PNS criteria.
Patient already receiving home-based treatment with Privigen®

Exclusion Criteria:

Not applicable

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: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy Time Frame: 52 weeks	The conventional method of home monitoring requires using a visiting nurse. HOME LINK is a telemonitoring system that is an alternative to this conventional method offering remote at-home monitoring. HOME LINK monitors the patient's health parameters from home. In this way it enables an adjustment of the infusion conditions or intervention of a qualified healthcare professional in the event of an incident. Home Link will be evaluated for failure rate of connection to the telemonitoring platform, failure rate of transmission of self-measurements to the telemonitoring platform, failure rate of transmission of documents relating to home-based treatment, and failure rate of contacting one of the healthcare professionals involved in patient care during the at-home infusions.	52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

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)

November 27, 2017

Primary Completion (Actual)

June 3, 2019

Study Completion (Actual)

June 3, 2019

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

IgPro10_5004
2016-A00147-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.