NCT02968394

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

November 11, 2016

Last Update Submit

November 18, 2016

Conditions

AllergyBee VenomImmunotherapyOmalizumab

Outcome Measures

Primary Outcomes (1)

  • Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.

    2 months

Secondary Outcomes (1)

  • Changes in basophil sensitivity during omalizumab co-treatment

    2 years

Study Arms (1)

NEVIT

EXPERIMENTAL

Co treatment with omalizumab during another attempt of immunotherapy introduction

Drug: omalizumab

Interventions

omalizumabDRUG
NEVIT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • systemic mastocytosis,
  • pregnancy,
  • use of beta-adrenergic blocking agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Pulmonary and Allergic Diseases Golnik

Golnik, 4204, Slovenia

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Mitja Košnik, MD, PhD

    University Clinic of Pulmonary and Allergic Diseases Golnik

    STUDY DIRECTOR

Central Study Contacts

Peter Kopac, MD

CONTACT

+386 4 25 69 100peter.kopac@klinika-golnik.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 18, 2016

Study Start

March 1, 2014

Primary Completion

March 1, 2017

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

SL(1)