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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2027
  • participants needed
    120
  • sponsor
    Inmunotek S.L.
Updated on 17 January 2025

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.

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.

Details
Condition Allergy, Insect Venom, Allergy Insect Stinging, Insect Sting Allergy
Age 14years or above
Clinical Study IdentifierNCT06782217
SponsorInmunotek S.L.
Last Modified on17 January 2025

Eligibility

Yes No Not Sure

Inclusion Criteria

The study population consisted of allergic participants indicated for treatment with immunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according to standard clinical practice
Age equal to or older than 14 years, without gender differences
Not having received immunotherapy with hymenoptera venom in the previous 5 years
That they agree to participate in the study and sign the informed consent form. In the case of minors, the parent or guardian of the participant must also sign the informed consent form

Exclusion Criteria

Pregnant or breastfeeding women
Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study
Participants who do not agree to participate and/or do not sign the informed consent form
Participants who do not comply with the medical indications or do not show cooperation with respect to the immunotherapy treatment
Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment
Participants in whom the administration of immunotherapy is contraindicated
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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