Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).
研究概览
简要总结
Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.
详细描述
Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.
- •Participants of both sexes aged 14 years or more.
- •Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.
- •Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.
排除标准
- •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 medical indications or do not cooperate with immunotherapy treatment.
研究组 & 干预措施
Patients allergic to hymenoptera venom
Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07)
干预措施: VENOX (Biological)
结局指标
主要结局
Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).
时间窗: 12 months
Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).
次要结局
- Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural stings during the 1-year follow-up.(12 months)
- Immunological parameters of the participants after 12 months of treatment.(12 months)
- SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.(12 months)