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

Sponsor
Carsten Bindslev-Jensen
Study ID
NCT03964051
Phase
PHASE4
Status
Terminated

Conditions

  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 1, 2019
Status verified
Dec 2023
Primary completion
Dec 21, 2020
Completion
Dec 21, 2020

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab 300 mg for s.c.injection
    Omalizumab 300 mg steril solution in prefilled syringes are administrated every 2. week for 12 weeks

Primary Outcome Measure

Change in food challenge threshold (as measured in amount of food protein in milligrams tolerated by oral challenge) [ Time Frame: 18 weeks ]

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