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

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Novartis

Status and phase

Completed
Phase 2

Conditions

Atopic Asthma

Treatments

Device: POCT device
Procedure: Blood sample

Study type

Interventional

Funder types

Industry

Identifiers

NCT02758548
CDIGE0012201

Details and patient eligibility

About

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.

Enrollment

193 patients

Sex

All

Ages

6+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

193 participants in 1 patient group

Capillary Blood Sampling
Other group
Description:
Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples
Treatment:
Procedure: Blood sample
Device: POCT device

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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