Treatment with Omalizumab in food allergic children - TOFAC

Odense Research Centre for Anaphylaxis (ORCA)0 个研究点目标入组 100 人开始时间: 2019年1月4日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•100 children between 6 and 18 years with a clinical diagnosis of food allergy to =1 food allergen, including a positive skin prick test (SPT) (mean wheal diameter > 3mm), specific IgE (s-IgE) > 0.35 kIU/l to the allergen in question, and 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) (Table 2). 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 specific IgE and when available challenge results within the last year) will be used.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Total IgE >1500 kU/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 effect
•Ongoing treatment with ß-blockers and ACE-inhibitors
•Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
•Alcohol abuse, abuse of opioids or other drugs in adolescents
•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
•Occurrence of unexpected side effects
•Patients who have reduced liver function or kidney function

发起方

Odense Research Centre for Anaphylaxis (ORCA)