Oral Immunotherapy (OIT) for Peanut Allergy
Completed · Phase 2 · Has a placebo group
Conditions studied: Peanut Hypersensitivity
In brief
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).
Key facts
- Study ID
- NCT00815035
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 16
- Starts
- 2009-04-01
- Expected to finish
- 2016-12-12
- Last updated by the study team
- 2018-03-01
Who can join
Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
- The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L
- A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
- Provide signed informed consent
You may not qualify if…
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
- Currently participating in a study using an investigational new drug
- Participation in any interventional study for the treatment of food allergy in the past 12 months
- Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
- Poor control or persistent activation of atopic dermatitis
- Moderate to severe persistent asthma
- Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
- Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs)
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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