Status:
COMPLETED
Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)
Lead Sponsor:
Carsten Bindslev-Jensen
Collaborating Sponsors:
Novartis Pharmaceuticals
Thermo Fisher Scientific, Inc
Conditions:
Food Allergy
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often m...
Detailed Description
Randomized, double-blind, placebo-controlled study to study the effect of Omalizumab on children with food allergy. Primary endpoint: Change in challenge threshold after 3 months of treatment in pati...
Eligibility Criteria
Inclusion
- children between 6 and 18 years
- a clinical diagnosis of food allergy to ≥1 food allergen
- a positive SPT (mean wheal diameter \> 3 mm)
- s-IgE \> 0.35 kIU/l
- a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC).
- (If the patient is allergic to more than one food allergen, the allergen with the highest probability of fulfilling the inclusion criteria (based on case history, level of s-IgE and when available challenge results within the last year) will be used).
Exclusion
- t-IgE \>1500 kIU/L.
- Significant co-morbidity that might compromise the patient's safety or study outcomes.
- Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken.
- Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused during the study
- Ongoing treatment with drugs that may impair safety during food challenge e.g. β-blockers or ACE-inhibitors that cannot be paused during the study
- Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
- Alcohol abuse, abuse of opioids or other drugs in adolescents
- Treated with Omalizumab until ½ years before the study
- Patients/parents who are not supposed to be able to meet the requirements in the protocol
- Patients/parents who are physically or mentally unable to consent
- Patients who have reduced liver function or kidney function
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04037176
Start Date
November 1 2019
End Date
March 15 2022
Last Update
December 5 2023
Active Locations (1)
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1
Odense Research Center for Anaphylaxis, Allergy Center, Odense University Hospital
Odense C, Funen, Denmark, 5000