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Trial record 7 of 50 for:    Polyneuropathies | CIDP

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

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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

Tracking Information
First Submitted Date December 14, 2018
First Posted Date December 19, 2018
Last Update Posted Date December 19, 2018
Actual Study Start Date November 27, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2018)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
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®)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients receiving home-based IVIg therapy with Privigen
Condition Chronic Inflammatory Demyelinating Polyneuropathy
Intervention Device: HOME LINK
Telemonitoring system which include web platform and connected devices.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 17, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Clinical Trials Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03779828
Other Study ID Numbers IgPro10_5004
2016-A00147-44 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party CSL Behring
Study Sponsor CSL Behring
Collaborators Not Provided
Investigators Not Provided
PRS Account CSL Behring
Verification Date December 2018