Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom

NCT ID: NCT04112797

Last Updated: 2022-03-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-23

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergy to Himenoptera Venom

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allergovac himenoptera

Treatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1\. Patients over 14 years of age with allergy to bee venom, Polistes or Vespula. To meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific IgE detection in the skin test and / or IgE against the himenoptera venom.

2\. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.

3\. Patients who have given their written consent. In the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor.

Exclusion Criteria

1. Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
2. Patients under treatment with immunotherapy against aeroallergens.
3. Patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study.
4. Patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires.
5. Patients who are participating in another clinical trial or observational study.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Roxall Medicina España S.A

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Vega Baja Orihuela

Orihuela, Alicante, Spain

Site Status RECRUITING

Hospital Mexoeiro

Vigo, Pontevedra, Spain

Site Status COMPLETED

C.H.U. A Coruña

A Coruña, , Spain

Site Status RECRUITING

Hospital Santa Maria

Lleida, , Spain

Site Status RECRUITING

Hospital Fundación Alcorcón

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofia

Murcia, , Spain

Site Status NOT_YET_RECRUITING

Hospital Joan XXIII

Tarragona, , Spain

Site Status RECRUITING

Hospital Universitario La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

María Cruz Gómez, MP

Role: CONTACT

+34 944438000

Leire Begoña

Role: CONTACT

+34 944438000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Angel Ferrer

Role: primary

Antonio Parra, Dr.

Role: primary

lluis Marqués, MP

Role: primary

Teresa Alfaya, Dr.

Role: primary

Antonio Carbonell, Dr.

Role: primary

Gaspar Dalmau, MP

Role: primary

Dolores Hernández, MP

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ROX-ALE-2018-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Immunotherapy for Peanut Allergic Patients
NCT04163562 RECRUITING PHASE1/PHASE2