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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Number of adverse events in the treatment population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 35
Study Start Date: November 2011
Estimated 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
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01510626     History of Changes
Other Study ID Numbers: 22872
Study First Received: November 29, 2011
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Multiple food allergies

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

ClinicalTrials.gov processed this record on October 16, 2014