Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Completed · Phase 1
Conditions studied: Immune System Diseases
In brief
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.
Key facts
- Study ID
- NCT01510626
- Run by
- Stanford University
- People needed
- 35
- Starts
- 2011-11-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2015-12-10
Who can join
Age: 4 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.