Status:
COMPLETED
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Lead Sponsor:
Stanford University
Conditions:
Immune System Diseases
Eligibility:
All Genders
4-55 years
Phase:
PHASE1
Brief Summary
The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize tha...
Eligibility Criteria
Inclusion
- Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
- Sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.
Exclusion
- No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
- Subjects with a total IgE at screening of \>2,000 kU/L
- Previous reaction to omalizumab
- Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01510626
Start Date
November 1 2011
End Date
December 1 2015
Last Update
December 10 2015
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305