Last updated: October 18, 2023
Sponsor: Imperial College London
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Allergy (Peanut)
Allergies & Asthma
Allergy
Treatment
Defatted roasted peanut flour
Boiled peanut
Clinical Study ID
NCT03937726
19SM5033
Ages 7-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 7-18 years (enrolment up to a participant's 19th birthday).
- Past history consistent with IgE-mediated peanut allergy
- Allergic to ≤1.44 g peanut protein (approx. 6 peanuts) at baseline double-blindplacebo-controlled food challenge, prior to treatment allocation
- Tolerates at least 1/8 boiled peanut (boiled for 4 hours) at open food challenge atscreening.
- Written informed consent of parent/legal guardian and patient assent.
Exclusion
Exclusion Criteria:
- Required previous admission to an intensive care unit for management of an allergicreaction to peanut.
- Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and notyet established on maintenance dosing for at least 3 months.
- Undergoing oral immunotherapy for food allergy and within the first year of treatment.
- Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or ACEinhibitor.
- Tolerance to ≥1.44 g peanut protein (approx. 6 peanuts) at initial DBPCFC duringscreening.
- Dose-limiting symptoms to 1/8 boiled peanut (boiled for 4 hours) at screening.
- Poorly controlled asthma within the previous 3 months (as defined by clinicianjudgement with reference to the ICON consensus ), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months.
- Pregnancy
- Unwilling or unable to fulfil study requirements
Study Design
Total Participants: 83
Treatment Group(s): 2
Primary Treatment: Defatted roasted peanut flour
Phase:
Study Start date:
April 29, 2019
Estimated Completion Date:
May 31, 2027
Connect with a study center
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London,
United KingdomSite Not Available
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