Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03779828
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Chronic Inflammatory Demyelinating Polyneuropathy Device: HOME LINK

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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®)
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: HOME LINK
    Telemonitoring system which include web platform and connected devices.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving home-based IVIg therapy with Privigen
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03779828


Contacts
Layout table for location contacts
Contact: Clinical Trials Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
Layout table for location information
France
Hôpital Pellegrin, Bordeaux University Hospital (CHU) Recruiting
Bordeaux, France
Contact: Clinical Trials Registration Coordinator         
Hôpital Henri Mondor - APHP Recruiting
Créteil, France
Contact: Clinical Trials Registration Coordinator         
Hôpital Roger Salengro - CHRU Recruiting
Lille, France
Contact: Clinical Trials Registration Coordinator         
Hôpital Pierre Wertheimer - HCL Recruiting
Lyon, France
Contact: Clinical Trials Registration Coordinator         
Hôpital La Timone - APHM Recruiting
Marseille, France
Contact: Clinical Trials Registration Coordinator         
Hôpital Gui de Chauliac - Montpellier University Hospital (CHU) Recruiting
Montpellier, France
Contact: Clinical Trials Registration Coordinator         
Hôpital Pasteur 2 - Nice University Hospital (CHU) Recruiting
Nice, France
Contact: Clinical Trials Registration Coordinator         
Hôpital La Pitié-Salpêtrière - APHP Recruiting
Paris, France
Contact: Clinical Trials Registration Coordinator         
Hôpital Lariboisière - APHP Recruiting
Paris, France
Contact: Clinical Trials Registration Coordinator         
Hôpital Nord - Saint Etienne University Hospital (CHU) Recruiting
Saint Etienne, France
Contact: Clinical Trials Registration Coordinator         
Sponsors and Collaborators
CSL Behring
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03779828     History of Changes
Other Study ID Numbers: IgPro10_5004
2016-A00147-44 ( Other Identifier: ANSM )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CSL Behring:
CIDP
telemonitoring
telemedicine

Additional relevant MeSH terms:
Layout table for MeSH terms
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