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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
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

Resource links provided by NLM:


Further study details as provided by Kari Christine Nadeau, Stanford University:

Primary Outcome Measures:
  • Number of adverse events in the treatment population [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Number of subjects who reach 2g or more of food flour [ Time Frame: 2 years ]

Enrollment: 35
Study Start Date: November 2011
Study Completion Date: December 2015
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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510626

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
  More Information

Responsible Party: Kari Christine Nadeau, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01510626     History of Changes
Obsolete Identifiers: NCT02062814
Other Study ID Numbers: 22872
Study First Received: November 29, 2011
Last Updated: December 9, 2015

Keywords provided by Kari Christine Nadeau, Stanford University:
Multiple food allergies

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on June 26, 2017