Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 4 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | December 2015 |
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 that the application of this protocol will allow patients with
severe and single or multiple food allergies to be safely and rapidly desensitized.
for, and to potentially cure patients with single or multiple food allergies. The
investigators hypothesize that the application of this protocol will allow patients with
severe and single or multiple food allergies to be safely and rapidly desensitized.
Inclusion Criteria:
- 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 Criteria:
- 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.
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