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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01510626
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University

Tracking Information
First Submitted Date  ICMJE November 29, 2011
First Posted Date  ICMJE January 16, 2012
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE November 2011
Actual 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 ]
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Official Title  ICMJE Omalizumab With Oral Food Immunotherapy 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  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune System Diseases
Intervention  ICMJE
  • Dietary Supplement: Food proteins
    Food proteins
  • Drug: Omalizumab
    Drug
Study Arms  ICMJE Experimental: One
Interventions:
  • Dietary Supplement: Food proteins
  • Drug: Omalizumab
Publications * Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2012)
35
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01510626
Other Study ID Numbers  ICMJE 22872
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kari Christine Nadeau, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date December 2015

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