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

Официальное название

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

Обзор

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

Подробное описание

This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltaven in Apis mellifera, Polistes dominula or Vespula spp (children and adults) in routine medical care.

Первичные конечные точки

• To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen [Срок оценки: 9 months]

Критерии участия

Критерии включения

• 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®.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 13 центров

• Hospital Universitario Vall d' Hebron — Barcelona
• Hospital Universitario de Bellvitge — Barcelona
• Xarxa Assistencial I Universitària de Manresa — Barcelona
• Hospital General Universitario de Castellón — Castellon
• Hospital General la Mancha Centro — Ciudad Real
• Hospital General Universitario de Ciudad Real — Ciudad Real
• Hospital Universitario Reina Sofía — Córdoba
• Hospital Santa Caterina de Girona — Girona
• … и ещё 5 центров

Идентификаторы

NCT: NCT07309822 · PRO-VEN-2023-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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