Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions

Allergy Clinical Trial

Official title:

Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02968394
• Other study ID #: NEVIT
• 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. 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

• Allergy
• Bee Venom
• Immunotherapy
• Omalizumab

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