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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Month - 5 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE GROUP

Inclusion Criteria:

  • - Male or female subjects aged 1 month to 5 years at Screening Visit - Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy - Subjects with any type of diet containing regular cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) within 1 month prior to Screening Visit - Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements.

Exclusion Criteria:

  • - Subjects with an established diagnosis of non-IgE mediated CMA - Breast-fed subject at Screening Visit - Subjects with a convincing history of IgE-mediated CMA - Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula within 1 month of Screening Visit.
  • - Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin.
- Any contraindication to a cow's milk challenge CONTROL GROUP

Inclusion Criteria:

- Male or female subjects aged 1 month to 5 years at Screening visit - Subjects having no medical history of any type of allergy - Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 1 month prior to Screening visit

Exclusion Criteria:

- Subjects with history of persistent gastro-intestinal symptoms - Breast-fed subjects

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04492683
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

DBV Technologies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Lithuania, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cow's Milk Allergy
Arms & Interventions

Arms

Experimental: Disease group

One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA

Experimental: Control group

One active patch and one control patch applied to subjects without any history of allergic disease

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Titan Clinical Research, Phoenix, Arizona

Status

Recruiting

Address

Titan Clinical Research

Phoenix, Arizona, 85004

Site Contact

Yadwinder Dhillon, MD

y.dhillon@viableresearch.org

623-262-0930

Eastern Research Inc., Hialeah, Florida

Status

Recruiting

Address

Eastern Research Inc.

Hialeah, Florida, 33013

Site Contact

Pilar Trueba, MD

trueba.fcs@gmail.com

305-681-3111

Biomedical Research, LLC, Miami, Florida

Status

Recruiting

Address

Biomedical Research, LLC

Miami, Florida, 33184

Site Contact

Lilia Roque Guerrero, MD

LroqueMD@Bio-MedicalResearch.com

305-554-5588

Sunshine Research Center, Opa-locka, Florida

Status

Not yet recruiting

Address

Sunshine Research Center

Opa-locka, Florida, 33054

Site Contact

Pierre Blemur, MD

maitemenendez@yahoo.com

305-688-0791

Oklahoma City, Oklahoma

Status

Recruiting

Address

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120

Site Contact

Martha Tarpay, MD

mtarpay@mtarpay.com

405-752-0393

International Sites

Hamilton Allergy, Hamilton, Ontario, Canada

Status

Not yet recruiting

Address

Hamilton Allergy

Hamilton, Ontario, L4A 1S4

Site Contact

Jason Ohayon, MD

ohayonj@hamiltonallergy.ca

905-525-4674

Kaunas, Lithuania

Status

Not yet recruiting

Address

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, , 50161

Site Contact

Jolanta Kudzyte, MD

jolantakudzyte@gmail.com

37068685286

Vilnius, Lithuania

Status

Not yet recruiting

Address

Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos, Department of Pediatrics

Vilnius, , 8406

Site Contact

Odilija Rudzeviciene, MD

odilija.rudzeviciene@vuvl.lt

37060820243

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