NCT03094845已完成2 期
Assessment of Safety and Clinical Tolerability of hdmASIT+TM Administered Subcutaneously in House Dust Mite-induced Allergic Rhinoconjunctivitis Patients
ASIT Biotech S.A.2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年9月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Solicited adverse events
研究概览
简要总结
hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001))
- •A positive skin prick test to house dust mite Dermatophagoides pteronyssinus
- •Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L
- •Positive response to Conjunctival Provocation Test (CPT)
- •Being treated with anti-allergic medication for at least 12 months prior to enrollment
- •For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value
排除标准
- •Previous immunotherapy with house dust mite allergens within the last 5 years
- •Ongoing immunotherapy with house dust mite allergens or any other allergens
- •History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
- •Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
- •Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient's reference value (ECSC)
- •History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
结局指标
主要结局
Solicited adverse events
时间窗: up to 7 weeks
* Local reactions at the injection site * Allergic systemic reactions
次要结局
- Unsolicited adverse events and serious adverse events (SAEs)(up to 12 weeks)
- Pulmonary functions (FEV1) for asthmatic patients(up to 7 weeks)
- Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure)(up to 12 weeks)
- Laboratory investigations (haematology, clinical biochemistry, immunological parameters)(up to 12 weeks)
研究者
研究点 (2)
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