Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy

Last updated: April 30, 2025
Sponsor: Inmunotek S.L.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergies & Asthma

Allergy (Pediatric)

Allergy

Treatment

VENOX

Clinical Study ID

NCT06782217
ITK-VENOX-2024-01
  • Ages > 14
  • All Genders

Study Summary

Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The study population consisted of allergic participants indicated for treatment withimmunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according tostandard clinical practice.

  2. Age equal to or older than 14 years, without gender differences.

  3. Not having received immunotherapy with hymenoptera venom in the previous 5 years.

  4. That they agree to participate in the study and sign the informed consent form. Inthe case of minors, the parent or guardian of the participant must also sign theinformed consent form.

Exclusion

Exclusion Criteria:

  1. Pregnant or breastfeeding women.

  2. Having received immunotherapy with hymenoptera venom during the 5 years prior to thestart of the study.

  3. Participants who do not agree to participate and/or do not sign the informed consentform.

  4. Participants who do not comply with the medical indications or do not showcooperation with respect to the immunotherapy treatment.

  5. Participants with oncological diseases under active treatment or with autoimmunediseases under immunosuppressive treatment.

  6. Participants in whom the administration of immunotherapy is contraindicated.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: VENOX
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
February 01, 2027

Study Description

Observational study to evaluate the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting (safety evaluation), also it will be evulated the quality of life of the patient using one QoL questionnair before and after immunotherapy treatment.

The patients aged equal or more than 14 years old, not gender differentiation, and sensitised to heminoptera venom. The total number of participants is expected to be 120.

This study will be conducted in Spain (multicentric) and data will be collected prospectively.

Connect with a study center

  • Hospital Arquitecto Marcide

    Ferrol, A Coruña 15405
    Spain

    Site Not Available

  • Hospital de Navarra

    Pamplona, Comunidad Foral de Navarra 31008
    Spain

    Site Not Available

  • Hospital Virgen del Puerto Plasencia

    Plasencia, Cáceres 10600
    Spain

    Active - Recruiting

  • Hospital Público Da Mariña

    Burela De Cabo, Lugo 27880
    Spain

    Active - Recruiting

  • Hospital Comarcal de Monforte de Lemos

    Monforte De Lemos, Lugo 27400
    Spain

    Active - Recruiting

  • Hospital de A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Vall d' Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005
    Spain

    Active - Recruiting

  • Hospital Universitario de Pontevedra

    Pontevedra, 36071
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.