RecruitingNot Applicable

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

Spain120 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range14 Years

SexALL

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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.

What they're measuring

Incidence of treatment-Emergent adverse reactions (safety and tolerability) in patients diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.) with indication to receive immunotherapy with the causative venom.

Timeframe: 12 months

Trial details

NCT IDNCT06782217

SponsorInmunotek S.L.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-11-01

Contact for this trial

Miguel Casanovas, MD

+3491208942 mcasanovas@inmunotek.com

View on ClinicalTrials.gov More Allergy, Insect Venom trials