Status:
UNKNOWN
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
Lead Sponsor:
DBV Technologies
Conditions:
Cow's Milk Allergy
Eligibility:
All Genders
29-24 years
Phase:
PHASE2
Brief 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) ...
Eligibility Criteria
Inclusion
- DISEASE GROUP
- 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.
Exclusion
- 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 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
- Inclusion Criteria:
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04492683
Start Date
August 28 2020
End Date
March 1 2024
Last Update
August 11 2022
Active Locations (33)
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1
Titan Clinical Research
Phoenix, Arizona, United States, 85004
2
University of Arizona Health Science
Tucson, Arizona, United States, 85719
3
University of California, Rady Children's Hospital
San Diego, California, United States, 92123
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045