Peanut Oral Immunotherapy for Children in Hong Kong

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, non-randomized study compares an 18-month peanut OIT protocol to standard peanut avoidance in children aged 2–17 with confirmed peanut allergy. The active arm plans 100 participants to receive OIT, while a control arm of 25 participants continues strict avoidance. Primary outcome is the proportion achieving desensitization above 640 mg peanut protein as confirmed by a food challenge after 18 months. Secondary aims include documenting treatment-related adverse events, discontinuations due to safety, and exploring plasma protein biomarkers linked to successful OIT. The trial seeks to establish a pragmatic, translatable model for peanut OIT in Hong Kong and to generate real-world evidence on effectiveness and safety beyond controlled trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject's parent and/ or guardian must be able to understand and provide informed consent.
* Age 2 to 17 years of age
* Either sex
* Any race, any ethnicity
* Have a history of sensitization \[positive skin prick test to peanut extract as defined by wheal size at least 3mm above control OR peanut-specific IgE ≥0.35 kUA/L\]

Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrolment:

* Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)
* History of chronic diseases requiring therapy (other than asthma, atopic dermatitis, allergic rhinitis)
* Past or current major illness that in the opinion of the Site investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant
* Concurrent treatment with any allergen immunotherapy
* Participation in any trials of therapeutic interventions for FA, or therapy with anti-IgE or other biologics within 1 year of enrolment
* Current uncontrolled or moderate to severe asthma as defined by FEV1 value \<80% predicted for participants aged 7 years or older and are able to perform spirometry
* Gastrointestinal eosinophilic disorders
* Use of short-acting antihistamine (e.g. chlorpheniramine) within 3 days prior to open-labelled food challenge or skin testing, or medium-acting antihistamine (e.g. cetirizine, loratadine) within 5 days prior to open-labelled food challenge or skin testing
* Use of beta-blockers, ACE inhibitors, angiotensin-receptor blockers or calcium channel blockers

Where it's running

• Department of Paediatrics, Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Sze Yin Agnes Leung, MBChB
• Email: agnes.syl@cuhk.edu.hk
• Phone: +85235052859

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.