Observational Prospective Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 13
- 主要终点
- To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen
研究概览
简要总结
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
详细描述
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.
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
- •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®.
排除标准
- •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.
结局指标
主要结局
To assess the clinical effectiveness of Beltaven® administered subcutaneously following a 3-week cluster dosing regimen
时间窗: 9 months
Proportion of patients who show tolerance (absence of systemic reaction) to the controlled sting challenge test conducted during the challenge visit, or to an accidental sting in a rural setting during the continuation treatment period
次要结局
未报告次要终点