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

NCT03964051 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-12-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Omalizumab Injection

Omalizumab 300 mg for subcutaneous injection

Sponsors & Collaborators

  • Miltenyi Biomedicine GmbH

    collaborator INDUSTRY

  • Carsten Bindslev-Jensen

    lead OTHER

Principal Investigators

  • Carsten Bindslev-Jensen, ProfDrMedPhd · Odense Research Center for Anaphylaxis

  • Charlotte G. Moertz, ProfMDPhd · Odense Research Center for Anaphylaxis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-12-21
Completion
2020-12-21

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964051 on ClinicalTrials.gov