Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects

November 13, 2016 updated by: Novartis Pharmaceuticals

A Multicenter Clinical Evaluation Study to Determine the External Site Accuracy of Total Immunoglobulin E Measurement Using a Novel Point of Care Test Device Compared to a Reference Method in Atopic Subjects

The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients.

120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 2

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

  • Germany
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Lübeck, Germany, 23552
        • Novartis Investigative Site
  • Italy
    • PD
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00168
        • Novartis Investigative Site
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Novartis Investigative Site
      • Harderwijk, Netherlands, 3840 AC
        • Novartis Investigative Site
  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46017
        • Novartis Investigative Site
  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • Novartis Investigative Site
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Novartis Investigative Site

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

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria: atopic patients

  • Subjects who are diagnosed with atopic condition
  • Subjects or legal guardians who are able to give informed consent
  • Other protocol-defined inclusion criteria may apply Exclusion criteria: atopic patients
  • Subjects who have received anti-IgE antibody treatment
  • Subjects who have elevated IgE levels for reasons other than allergic conditions
  • Other protocol-defined exclusion criteria may apply Inclusion criteria: healthy subjects
  • Subjects who are able to give informed consent for participation in the study according to local requirements / law.

Exclusion criteria: healthy subjects

  • Subjects who have received anti-IgE antibody treatment
  • Subjects with a suspected or confirmed clinical diagnosis of an atopic condition
  • Other protocol-defined exclusion criteria may apply

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Capillary Blood Sampling
Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples
Procedure: Blood sample
Fingerprick and venous
Device: POCT device
Investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total IgE concentration
Time Frame: Day 0 or Day 1 (Visit 2: Blood sampling)

Total IgE concentration in capillary blood measured with the POCT device at Day 0 or Day 1 from enrollment.

Total IgE concentration in venous blood measured with the reference method at Day 0 or Day 1 from enrollment.
Day 0 or Day 1 (Visit 2: Blood sampling)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device usability questionnaire response
Time Frame: Day 0 or Day 1 (Visit 2: Blood sampling)
Device usability assessment of the POCT device as per operators at the completion of the study.
Day 0 or Day 1 (Visit 2: Blood sampling)

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

March 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 13, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDIGE0012201

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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