Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).

NCT03964051 PHASE4 TERMINATED

Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen. Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.

Details

Lead sponsor	Carsten Bindslev-Jensen
Phase	PHASE4
Status	TERMINATED
Enrolment	7
Start date	Mon Jul 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Dec 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Food Allergy

Interventions

• Omalizumab Injection

Countries

Denmark