Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.

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

Phase

N/A

Condition

Allergies & Asthma

Allergy

Treatment

VENOX

Clinical Study ID

NCT06790368
ITK-VENOX-2023-01
  • Ages > 14
  • All Genders

Study Summary

Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The study population consisted of allergic participants indicated for treatment withhymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according tostandard clinical practice.

  • Participants of both sexes aged 14 years or more.

  • Participants who have not received immunotherapy with hymenoptera venom in theprevious 5 years.

  • Participants who have agreed to take part in the study and sign the informed consentform. In the case of minors, the patient's parent or guardian must also sign.

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding women.

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

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

  • Participants who do not comply with medical indications or do not cooperate withimmunotherapy treatment.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: VENOX
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
June 01, 2026

Study Description

Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.

Connect with a study center

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid 28922
    Spain

    Active - Recruiting

  • Hospital Reina Sofía

    Córdoba,
    Spain

    Active - Recruiting

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002
    Spain

    Active - Recruiting

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