Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
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 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.
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 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.
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 immunotherapy (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 patients diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.) with indication to receive immunotherapy with the causative venom.
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 immunogenicity of the participant after 6 and 12 months of treatment.(12 months)
- Quality of life in treated participants after 6 and 12 months of treatment.(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.(12 months)