- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03779828
Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP (HELIPAD 1)
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bordeaux, France
- Hôpital Pellegrin, Bordeaux University Hospital (CHU)
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Créteil, France
- Hôpital HENRI MONDOR - APHP
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Lille, France
- Hôpital Roger Salengro - CHRU
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Lyon, France
- Hôpital Pierre WERTHEIMER - HCL
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Marseille, France
- Hôpital La Timone - APHM
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Montpellier, France
- Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)
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Nice, France
- Hôpital Pasteur 2 - Nice University Hospital (CHU)
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Paris, France
- Hôpital La Pitié-Salpêtrière - APHP
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Paris, France
- Hopital Lariboisiere - APHP
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Saint Etienne, France
- Hôpital Nord - Saint Etienne University Hospital (CHU)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
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52 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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