Status:
COMPLETED
Oral Peanut Immunotherapy for Peanut Allergic Patients
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Peanut Hypersensitivity
Eligibility:
All Genders
1-16 years
Phase:
EARLY_PHASE1
Brief Summary
This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.
Detailed Description
The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our extensive knowledge of the allergens involved in peanut hyperse...
Eligibility Criteria
Inclusion
- Subjects between 1 and 16 years of age
- Diagnosed peanut allergy by either: 1) a positive prick skin test to peanut, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanut, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
- A family that will be able to be compliant with all study visits.
Exclusion
- Subjects with a history of severe anaphylaxis to peanut
- Subjects with a medical history that would prevent a DBPCFC/OFC to peanut The medical history that would prevent the DBPCFC to peanut would be a prior history of an open peanut challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an forced expiratory volume in 1 second (FEV1) \< 80% of predicted, or FEV1/FVC (forced vital capacity) \< 75%, with or without controller medications
- Subjects unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
- Pregnant or lactating
- Allergy to oat
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01891136
Start Date
April 1 2004
End Date
December 1 2014
Last Update
June 25 2015
Active Locations (1)
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1
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599