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Last Updated: September 21, 2020

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CLINICAL TRIALS PROFILE FOR EPINEPHRINE (AUTOINJECTOR)

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All Clinical Trials for EPINEPHRINE (AUTOINJECTOR)

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03964051 Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). Recruiting Miltenyi Biotec GmbH Phase 4 2019-07-01 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.
NCT03964051 Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). Recruiting Carsten Bindslev-Jensen Phase 4 2019-07-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for EPINEPHRINE (AUTOINJECTOR)

Condition Name

Condition Name for EPINEPHRINE (AUTOINJECTOR)
Intervention Trials
Food Allergy 1
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Condition MeSH

Condition MeSH for EPINEPHRINE (AUTOINJECTOR)
Intervention Trials
Food Hypersensitivity 1
Anaphylaxis 1
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Clinical Trial Locations for EPINEPHRINE (AUTOINJECTOR)

Trials by Country

Trials by Country for EPINEPHRINE (AUTOINJECTOR)
Location Trials
Denmark 1
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Clinical Trial Progress for EPINEPHRINE (AUTOINJECTOR)

Clinical Trial Phase

Clinical Trial Phase for EPINEPHRINE (AUTOINJECTOR)
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

Clinical Trial Status for EPINEPHRINE (AUTOINJECTOR)
Clinical Trial Phase Trials
Recruiting 1
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Clinical Trial Sponsors for EPINEPHRINE (AUTOINJECTOR)

Sponsor Name

Sponsor Name for EPINEPHRINE (AUTOINJECTOR)
Sponsor Trials
Carsten Bindslev-Jensen 1
Miltenyi Biotec GmbH 1
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Sponsor Type

Sponsor Type for EPINEPHRINE (AUTOINJECTOR)
Sponsor Trials
Other 1
Industry 1
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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Colorcon
Dow

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