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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University
ClinicalTrials.gov Identifier:
NCT01510626
First received: November 29, 2011
Last updated: December 9, 2015
Last verified: December 2015
November 29, 2011
December 9, 2015
November 2011
April 2014   (Final data collection date for primary outcome measure)
Number of adverse events in the treatment population [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01510626 on ClinicalTrials.gov Archive Site
Number of subjects who reach 2g or more of food flour [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Immune System Diseases
  • Dietary Supplement: Food proteins
    Food proteins
  • Drug: Omalizumab
    Drug
Experimental: One
Interventions:
  • Dietary Supplement: Food proteins
  • Drug: Omalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2015
April 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
4 Years to 55 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01510626
22872
Yes
Not Provided
Not Provided
Kari Christine Nadeau, Stanford University
Stanford University
Not Provided
Not Provided
Stanford University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP