Food Allergen OIT for Shrimp and Cashew (NCT03504774) | Clinical Trial Compass
TerminatedPhase 2
Food Allergen OIT for Shrimp and Cashew
Stopped: Study discontinued due to slow enrollment during COVID-19 pandemic
United States58 participantsStarted 2019-07-09
Plain-language summary
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).
Who can participate
Age range7 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject and/or parent guardian must be able to understand and provide informed consent
* Age 7 through 55 years (inclusive)
* Clinical history of allergy to cashew or shrimp-containing foods
* Serum IgE to cashew or shrimp of ≥0.35 kUA/L \[determined by UniCAPTM within the past 12 months\] and/or a SPT to cashew or shrimp ≥3 mm compared to control
* Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines
* Written informed consent from adult participants
* Written informed consent from parent/guardian for minor participants
* Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements)
* All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
* Use of effective birth control by female participants of child-bearing potential.
Exclusion Criteria:
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* History of uncontrolled cardiovascular disease, including uncontrolled hypertension
* History of other chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) requiring therapy (e.g., heart disease, diabetes) that is, or is at significant risk of becoming unst…
What they're measuring
1
Expression of CD28 in the CD4+ Allergen Specific (CD154+)