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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03059589
Other study ID # Mylan-16-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2017
Est. completion date December 31, 2020

Study information

Verified date February 2021
Source Food Allergy Support Team
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.


Description:

Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date December 31, 2020
Est. primary completion date August 20, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food, - no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food Exclusion Criteria: - pregnancy - severe asthma - poorly controlled atopic dermatitis - eosinophilic esophagitis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Food Allergy Center of FL Sarasota Florida

Sponsors (1)

Lead Sponsor Collaborator
Food Allergy Support Team

Country where clinical trial is conducted

United States, 

References & Publications (2)

Nachshon L, Goldberg MR, Elizur A, Levy MB, Schwartz N, Katz Y. A Web site-based reporting system for monitoring home treatment during oral immunotherapy for food allergy. Ann Allergy Asthma Immunol. 2015 Jun;114(6):510-5. doi: 10.1016/j.anai.2015.04.007. Epub 2015 May 1. — View Citation

Wasserman RL, Factor JM, Baker JW, Mansfield LE, Katz Y, Hague AR, Paul MM, Sugerman RW, Lee JO, Lester MR, Mendelson LM, Nacshon L, Levy MB, Goldberg MR, Elizur A. Oral immunotherapy for peanut allergy: multipractice experience with epinephrine-treated reactions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):91-6. doi: 10.1016/j.jaip.2013.10.001. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy of food allergy treatment the percentage of patients who successfully reach the maintenance dose of food 3 years
Secondary epinephrine use The frequency of epinephrine use during the course of oral immunotherapy as reported in the prospective database. Also, identify factors that are associated with the need for epinephrine. 3 years
Secondary factors associated with the failure to reach the target dose of food ingestion Identify factors that are associated with treatment failures through analysis of patient demographics, baseline laboratory test results, and concomitant atopic conditions. 3 years
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