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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02968394
Other study ID # NEVIT
Secondary ID
Status Recruiting
Phase N/A
First received November 11, 2016
Last updated November 18, 2016
Start date March 2014

Study information

Verified date November 2016
Source The University Clinic of Pulmonary and Allergic Diseases Golnik
Contact Peter Kopac, MD
Phone +386 4 25 69 100
Email peter.kopac@klinika-golnik.si
Is FDA regulated No
Health authority Slovenia: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 11
Est. completion date
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
omalizumab


Locations

Country Name City State
Slovenia University Clinic of Pulmonary and Allergic Diseases Golnik Golnik

Sponsors (1)

Lead Sponsor Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment. 2 months No
Secondary Changes in basophil sensitivity during omalizumab co-treatment 2 years No
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