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Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children

NCT04492683 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2022-08-11

No results posted yet for this study

Summary

Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.

Conditions

  • Cow's Milk Allergy

Interventions

COMBINATION_PRODUCT

DBV1605

Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches: * One active patch containing a dry deposit of 180 μg of cow's milk proteins * One control patch with the same design as the active patch but devoid of any formulation.

Sponsors & Collaborators

  • DBV Technologies

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Italy
  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492683 on ClinicalTrials.gov