Omalizumab With Oral Food Immunotherapy in Children and Adults With Food Allergies Open Label Safety Study in a Single Center
This study is ongoing, but not recruiting participants.
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01510626
First received: November 29, 2011
Last updated: May 2, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Immune System Diseases |
Dietary Supplement: Food proteins Drug: Omalizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Omalizumab With Oral Food Immunotherapy in Children and Adults With Food Allergies Open Label Safety Study in a Single Center |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Number of adverse events in the treatment population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of subjects who reach 2g or more of food flour [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 35 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: One |
Dietary Supplement: Food proteins
Food proteins
Drug: Omalizumab
Drug
|
Eligibility| Ages Eligible for Study: | 4 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01510626 History of Changes |
| Other Study ID Numbers: | 22872 |
| Study First Received: | November 29, 2011 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Stanford University:
|
Multiple food allergies |
Additional relevant MeSH terms:
|
Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate Hypersensitivity Omalizumab |
Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013