Omalizumab Treatment in Venom Immunotherapy With Systemic... | NCT02968394

Studies
Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions

NCT02968394

Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Status

Unknown status

Last Update Posted

Nov 21, 2016Estimated

Enrollment

11Estimated

Phase

Not Applicable

Conditions

Allergy
Bee Venom
Immunotherapy
Omalizumab

Interventions

omalizumab

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2017Estimated

Completion Date

Not provided

First Submitted Date

Nov 11, 2016

First Submission Date that Met QC Criteria

Nov 16, 2016

First Posted Date

Nov 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2016

Last Update Posted Date

Nov 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NEVIT	Experimental	Co treatment with omalizumab during another attempt of immunotherapy introduction	Drug: omalizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
omalizumab	Drug		NEVIT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.		2 months

Secondary Outcomes

Measure	Description	Time Frame
Changes in basophil sensitivity during omalizumab co-treatment		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Kopac, MD	Contact	+386 4 25 69 100		peter.kopac@klinika-golnik.si

Overall Officials

Name	Affiliation	Role
Mitja Košnik, MD, PhD	University Clinic of Pulmonary and Allergic Diseases Golnik	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic of Pulmonary and Allergic Diseases Golnik	Recruiting	Golnik		4204	Slovenia

ID	Term
D006967	Hypersensitivity

ID	Term
D007154	Immune System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000069444	Omalizumab

Ancestor Terms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided