Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
NCT ID: NCT04492683
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
230 participants
INTERVENTIONAL
2020-08-28
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Disease group
One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
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.
Control group
One active patch and one control patch applied to subjects without any history of allergic disease
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy
* Subjects with any type of diet containing daily products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior to Screening Visit or who have started a cow's milk elimination diet not more than 4 weeks 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.
* Male or female subjects aged \> 28 days to ≤ 24 months 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 4 weeks prior to Screening visit
Exclusion Criteria
* 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 initiated more than 4 weeks prior to 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
* Subjects with history of persistent gastro-intestinal symptoms
* Exclusively breast-fed subjects at Screening visit
29 Days
24 Months
ALL
Yes
Sponsors
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DBV Technologies
INDUSTRY
Responsible Party
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Locations
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Titan Clinical Research
Phoenix, Arizona, United States
University of Arizona Health Science
Tucson, Arizona, United States
University of California, Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Eastern Research Inc.
Hialeah, Florida, United States
Biomedical Research, LLC
Miami, Florida, United States
Sunshine Research Center
Opa-locka, Florida, United States
Allergy Center at Brookstone - Research Department
Columbus, Georgia, United States
MedPharmics, LLC - Lafayette
Lafayette, Louisiana, United States
Massachusets General Hospital
Boston, Massachusetts, United States
New York University Langone Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
Rochester, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Alliance for Multispecialty Research, LLC - New Roy Office
Roy, Utah, United States
Halton Pediatric Allergy
Burlington, Ontario, Canada
Hamilton Allergy
Hamilton, Ontario, Canada
Gordon Sussman Clinical Research Inc.
North York, Ontario, Canada
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina
Palermo, , Italy
IRCCS Fondazione Policlinico San Matteo - Pediatria
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Pisa, , Italy
IRCCS Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, , Italy
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics
Vilnius, , Lithuania
Countries
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Facility Contacts
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Other Identifiers
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V1605-201
Identifier Type: -
Identifier Source: org_study_id
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