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Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions

NCT ID: NCT02968394

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

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The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.

Detailed Description

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Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.

Conditions

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Allergy Bee Venom Immunotherapy Omalizumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NEVIT

Co treatment with omalizumab during another attempt of immunotherapy introduction

Group Type EXPERIMENTAL

omalizumab

Intervention Type DRUG

Interventions

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omalizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
* honey-bee venom immunotherapy treatment failure due to systemic reactions.

Exclusion Criteria

* systemic mastocytosis,
* pregnancy,
* use of beta-adrenergic blocking agents.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitja Košnik, MD, PhD

Role: STUDY_DIRECTOR

University Clinic of Pulmonary and Allergic Diseases Golnik

Locations

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University Clinic of Pulmonary and Allergic Diseases Golnik

Golnik, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Peter Kopac, MD

Role: CONTACT

Phone: +386 4 25 69 100

Email: [email protected]

Facility Contacts

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Peter Kopac, MD

Role: primary

Other Identifiers

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NEVIT

Identifier Type: -

Identifier Source: org_study_id