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RecruitingNCT07309822

Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.

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Trial Parameters

ConditionAllergy
SponsorProbelte Pharma S.L.U.
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment27
SexALL
Min Age14 Years
Max AgeN/A
Start Date2025-02-01
Completion2031-05

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Brief Summary

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltaven® With Apis mellifera, Polistes dominula or Vespula spp. allergic patients

Eligibility Criteria

Inclusion Criteria: * Age 14 years or older at the time of study inclusion. * Written informed consent, duly signed and dated by the patient or by the legal representative in the case of minors. * Assent form duly signed and dated by the minor, when applicable. * Patients with allergy to Apis mellifera, Vespula spp., or Polistes dominula who have experienced a systemic reaction following a hymenoptera sting, either with involvement of multiple organs or exclusively cutaneous. * Positive intradermal test (mean wheal diameter ≥ 5 mm) with Beltaven® diagnostic (allergenic extract of Apis mellifera, Vespula spp., or Polistes dominula). * Positive specific IgE test from class 1 onwards (≥ 0.35 kUA/L). * Patients willing to receive immunotherapy with Beltaven®. Exclusion Criteria: * Patients with severe cardiovascular diseases, active malignant neoplasms or malignancies in remission within the last 5 years, non-stabilized systemic or organ-specific autoimmune diseases, severe mental disorder

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