Trial Search Results

Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Dietary Supplement: Food proteins
  • Drug: Omalizumab

Phase:

Phase 1

Eligibility


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.

Ages Eligible for Study

4 Years - 55 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tina Dominguez, PA
safar_inquiry@stanford.edu
Not Recruiting