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:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 29, 2011
Last Updated Date	May 2, 2012
Start Date ^ICMJE	November 2011
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 11, 2012)	Number of adverse events in the treatment population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01510626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 11, 2012)	Number of subjects who reach 2g or more of food flour [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Omalizumab With Oral Food Immunotherapy in Children and Adults With Food Allergies Open Label Safety Study in a Single Center
Official Title ^ICMJE	Omalizumab With Oral Food Immunotherapy in Children and Adults With Food Allergies Open Label Safety Study in a Single Center
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 that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Immune System Diseases
Intervention ^ICMJE	Dietary Supplement: Food proteins Food proteins Drug: Omalizumab Drug
Study Arm (s)	Experimental: One Interventions: Dietary Supplement: Food proteins Drug: Omalizumab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	35
Completion Date	Not Provided
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	4 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01510626
Other Study ID Numbers ^ICMJE	22872
Has Data Monitoring Committee	Yes
Responsible Party	Stanford University
Study Sponsor ^ICMJE	Stanford University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Stanford University
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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