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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Stanford University.
Recruitment status was  Active, not recruiting
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

November 29, 2011
May 2, 2012
November 2011
April 2014   (final data collection date for primary outcome measure)
Number of adverse events in the treatment population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Omalizumab With Oral Food Immunotherapy in Children and Adults With Food Allergies Open Label Safety Study in a Single Center
Omalizumab With Oral Food Immunotherapy in Children and Adults 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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
35
Not Provided
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.
Both
4 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01510626
22872
Yes
Stanford University
Stanford University
Not Provided
Not Provided
Stanford University
May 2012

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