A Phase 2 Study to Evaluate the Sensitivity, Specificity and Safety of DBV1605, a Ready-to-Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow's Milk Allergy in Children
Status: Unknown
Location: See all (33) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 29 days
Maximum Age: 2
Healthy Volunteers: t
View:
• Male or female subjects aged \> 28 days to ≤ 24 months at Screening Visit
• 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
Locations
United States
Arizona
Titan Clinical Research
RECRUITING
Phoenix
University of Arizona Health Science
RECRUITING
Tucson
California
University of California, Rady Children's Hospital
NOT_YET_RECRUITING
San Diego
Colorado
Children's Hospital Colorado
WITHDRAWN
Aurora
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington
Florida
Eastern Research Inc.
WITHDRAWN
Hialeah
Biomedical Research, LLC
RECRUITING
Miami
Sunshine Research Center
NOT_YET_RECRUITING
Opa-locka
Georgia
Allergy Center at Brookstone - Research Department
WITHDRAWN
Columbus
Louisiana
MedPharmics, LLC - Lafayette
RECRUITING
Lafayette
Massachusetts
Massachusets General Hospital
RECRUITING
Boston
New York
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
New York University Langone Medical Center
RECRUITING
New York
University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
NOT_YET_RECRUITING
Rochester
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Case Western Reserve University (CWRU) - University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Oklahoma
Allergy, Asthma & Clinical Research Center
RECRUITING
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
Utah
Alliance for Multispecialty Research, LLC - New Roy Office
NOT_YET_RECRUITING
Roy
Other Locations
Canada
Halton Pediatric Allergy
RECRUITING
Burlington
Hamilton Allergy
RECRUITING
Hamilton
Gordon Sussman Clinical Research Inc.
WITHDRAWN
North York
Italy
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
Azienda Ospedaliera di Padova
RECRUITING
Padova
UOC Pediatria ad Indirizzo Gastroenterologico - Ospedale pediatrico Di Cristina
RECRUITING
Palermo
IRCCS Fondazione Policlinico San Matteo - Pediatria
RECRUITING
Pavia
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
RECRUITING
Pisa
IRCCS Ospedale Pediatrico Bambino Gesù
NOT_YET_RECRUITING
Roma
Università la Sapienza U.O.C di Gastroenterologia, Epatologia e Endoscopia Digestiva Pediatrica
RECRUITING
Roma
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
RECRUITING
Verona
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
RECRUITING
Kaunas
Vilnius University Hospital Santaros Klinikos, Centre of Pediatrics
RECRUITING
Vilnius
Time Frame
Start Date:2020-08-28
Completion Date:2024-03
Participants
Target number of participants:230
Treatments
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