RecruitingNCT07309822
Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
Observational Prospective Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp
Sponsor
Probelte Pharma S.L.U.
Enrollment
27 participants
Start Date
Feb 1, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 14 Years
Inclusion Criteria7
- 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 Criteria7
- 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 disorders, or other relevant chronic diseases that may interfere with the study results.
- Patients with known allergy to any of the vaccine excipients.
- Pregnant patients, patients planning to become pregnant during the study period, or breastfeeding patients.
- Patients who have received hymenoptera immunotherapy within the 5 years prior to inclusion or during the study.
- Patients who are to receive immunotherapy with another specific allergen different from the investigational treatment during the study period.
- Patients with confirmed sensitization to two or more hymenoptera species as demonstrated by CAP inhibition testing.
- Patients with thrombocytopenic purpura and vasculitis, rhabdomyolysis, or renal failure.
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Locations(13)
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NCT07309822
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