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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 November 2021 |
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Main ID: |
NCT02487420 |
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Date of registration:
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29/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Gradual Egg-tolerance Induction in Hen's Egg Allergic Children
TETI |
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Scientific title:
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Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie) |
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Date of first enrolment:
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July 1, 2015 |
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Target sample size:
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86 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02487420 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Dominique MA Bullens, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UZ Leuven |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Children (1-18y) had or have a clinical diagnosis of IgE mediated hen's egg allergy
based on positive history as well as skin prick testing and/or specific IgE detection
by CAPtest in an allergy clinic
2. Children are at least 12 months old before introduction of heated egg is considered
3. Children did not suffer from a moderate-to-severe anaphylaxis due to egg-ingestion at
presentation
4. Children have specific IgE levels to Gal d 1 below 1.2 kU/mL or passed cake
provocation test -
Exclusion Criteria:
1. Children had a moderate-to severe anaphylaxis due to egg ingestion
2. Children are younger than 12 months old at the moment of passing heated egg open
provocation test
3. Parents are not able or not willing to test a certain step in the tolerance induction
at home -
Age minimum:
12 Months
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Egg Hypersensitivity
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Intervention(s)
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Behavioral: shorter or longer period of specific dietary restrictions
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Primary Outcome(s)
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time to complete egg tolerance
[Time Frame: 18 to 30 months]
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Secondary Outcome(s)
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Measurement of specific IgE to egg white components to predict complete egg tolerance
[Time Frame: 18 to 30 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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