<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779828</url>
  </required_header>
  <id_info>
    <org_study_id>IgPro10_5004</org_study_id>
    <secondary_id>2016-A00147-44</secondary_id>
    <nct_id>NCT03779828</nct_id>
  </id_info>
  <brief_title>Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP</brief_title>
  <acronym>HELIPAD 1</acronym>
  <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®)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSL Behring</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSL Behring</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating&#xD;
      polyneuropathy of autoimmune origin with a progressive or relapsing course.&#xD;
&#xD;
      Diagnosis is based on clinical presentation and electrophysiological findings in accordance&#xD;
      with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown&#xD;
      to be effective in several placebo-controlled trials.&#xD;
&#xD;
      Once IVIg therapy produces a response and is well tolerated, some patients are able to&#xD;
      continue their treatment in the home setting. The HOME LINK system offers an integrated,&#xD;
      global solution based on telemonitoring technology providing continuous, remote monitoring of&#xD;
      Privigen® infusions administered at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to logistical concerns&#xD;
  </why_stopped>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">June 3, 2019</completion_date>
  <primary_completion_date type="Actual">June 3, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy</measure>
    <time_frame>52 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Chronic Inflammatory Demyelinating Polyneuropathy</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HOME LINK</intervention_name>
    <description>Telemonitoring system which include web platform and connected devices.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving home-based IVIg therapy with Privigen&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a diagnosis of CIDP as per EFNS/PNS criteria.&#xD;
&#xD;
          -  Patient already receiving home-based treatment with Privigen®&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Pellegrin, Bordeaux University Hospital (CHU)</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor - APHP</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Roger Salengro - CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pierre Wertheimer - HCL</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Timone - APHM</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pasteur 2 - Nice University Hospital (CHU)</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Pitié-Salpêtrière - APHP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Lariboisière - APHP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord - Saint Etienne University Hospital (CHU)</name>
      <address>
        <city>Saint Etienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CIDP</keyword>
  <keyword>Telemonitoring</keyword>
  <keyword>Telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Polyradiculoneuropathy, Chronic Inflammatory Demyelinating</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779828
org study id: IgPro10_5004
secondary id: 2016-A00147-44
nct id: NCT03779828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Prospective
measure: Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy
time frame: 52 weeks
description: 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.
intervention type: Device
intervention name: HOME LINK
description: Telemonitoring system which include web platform and connected devices.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Polyneuropathies
mesh term: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
sharing ipd: No