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

NCT ID: NCT01510626

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Immune System Diseases

Keywords

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Multiple food allergies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One

Group Type EXPERIMENTAL

Food proteins

Intervention Type DIETARY_SUPPLEMENT

Food proteins

Omalizumab

Intervention Type DRUG

Drug

Interventions

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Food proteins

Food proteins

Intervention Type DIETARY_SUPPLEMENT

Omalizumab

Drug

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Kari Christine Nadeau

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29296107 (View on PubMed)

Other Identifiers

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22872

Identifier Type: -

Identifier Source: org_study_id

NCT02062814

Identifier Type: -

Identifier Source: nct_alias