Status:
COMPLETED
Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Peanut Hypersensitivity
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.
Detailed Description
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-sp...
Eligibility Criteria
Inclusion
- Age 12 years and above 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 \[CAP-FEIA\] \> 5 kUA/L
- A history of significant clinical symptoms (urticaria, angioedema, rhinorrhea, nasal congestion, pruritis, sneezing, abdominal pain, emesis, diarrhea, wheezing, shortness of breath, lip/tongue swelling, throat itching, throat swelling, impending sense of doom) occurring within 60 minutes after ingesting peanuts
- Provide signed informed consent
- Women who are sexually active, must agree to use appropriate contraceptive measures for the duration of the study and for 9 months afterwards
Exclusion
- History of severe anaphylaxis to peanut or omalizumab 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 oat or wheat (because of potential cross contamination with oat) food allergy will be excluded
- 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)
- History of other serious underlying disease (i.e., heart disease, diabetes, etc.)
- Women who are pregnant or nursing
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00932282
Start Date
July 1 2009
End Date
August 1 2015
Last Update
March 1 2018
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599