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Идёт набор NCT06782217

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

— Наблюдательное Allergy, Insect Venom Allergy Insect Stinging Insect Sting Allergy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: VENOX.
Кому может быть актуально
Состояния в реестре: Allergy, Insect Venom, Allergy Insect Stinging, Insect Sting Allergy. Базовые параметры: от 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Биопрепарат VENOX
    Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.

Первичные конечные точки

  • 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. [Срок оценки: 12 months]
Вторичные конечные точки (3)
  • Evaluation of the immunogenicity of the participant after 6 and 12 months of treatment. [Срок оценки: 12 months]
  • Quality of life in treated participants after 6 and 12 months of treatment. [Срок оценки: 12 months]
  • Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural repicures during the 1-year follow-up. [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

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 · 9 центров
  • Hospital Arquitecto Marcide — Ferrol
  • Hospital Virgen del Puerto Plasencia — Plasencia
  • Hospital Público Da Mariña — Burela de Cabo
  • Hospital Comarcal de Monforte de Lemos — Monforte de Lemos
  • Hospital de A Coruña — A Coruña
  • Hospital Vall d' Hebron — Barcelona
  • Hospital Universitario Lucus Augusti — Lugo
  • Complejo Hospitalario Universitario de Ourense — Ourense
  • … и ещё 1 центр

Публикации

  • Oude Elberink JN, De Monchy JG, Van Der Heide S, Guyatt GH, Dubois AE. Venom immunotherapy improves health-related quality of life in patients allergic to yellow jacket venom. J Allergy Clin Immunol. 2002 Jul;110(1):174-82. doi: 10.1067/mai.2002.125827. PMID 12110838
  • Golden DB. Insect sting allergy and venom immunotherapy: a model and a mystery. J Allergy Clin Immunol. 2005 Mar;115(3):439-47; quiz 448. doi: 10.1016/j.jaci.2005.01.005. PMID 15753884
  • Bousquet J, Muller UR, Dreborg S, Jarisch R, Malling HJ, Mosbech H, Urbanek R, Youlten L. Immunotherapy with Hymenoptera venoms. Position paper of the Working Group on Immunotherapy of the European Academy of Allergy and Clinical Immunology. Allergy. 1987 Aug;42(6):401-13. doi: 10.1111/j.1398-9995.1987.tb00355.x. PMID 3310714
  • Demsar Luzar A, Korosec P, Kosnik M, Zidarn M, Rijavec M. Hymenoptera Venom Immunotherapy: Immune Mechanisms of Induced Protection and Tolerance. Cells. 2021 Jun 22;10(7):1575. doi: 10.3390/cells10071575. PMID 34206562

Идентификаторы

NCT: NCT06782217 · ITK-VENOX-2024-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗