NCT02601690终止不适用
Observational, Cross-sectional Analysis of T Cell Responses to Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs) for Multiple Allergens in Subjects With Allergy in North America
Adiga Life Sciences, Inc.2 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2015年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Evaluation of T cell responses to SPIREs
研究概览
简要总结
This is a research study intending to look at the response of a specific type of allergy cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a non-interventional study in which no investigational product will be administered to any subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-65 years.
- •Willing and able to provide written informed consent.
- •One year history of allergic rhinoconjunctivitis to one or more of cat, short ragweed, Rye grass, or HDM.
- •Positive skin prick test to each allergen for which a subject has a qualifying clinical history.
排除标准
- •Clinically relevant history of alcohol or drug abuse.
- •Use of any oral or parenteral (except low dose inhaled) corticosteroids within 2 months prior to the visit or any other immunosuppressive therapy within 3 months prior to the visit.
- •Vaccination/ inoculation within the 6 weeks prior to the first visit.
- •A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis).
- •Subjects who have taken an investigational drug within 6 weeks prior to the visit or are currently participating in any other clinical study.
- •Recent blood donation of an amount of >100 mL.
- •Immunotherapy within the last 5 years to any of the allergens for which a subject would otherwise be eligible on the basis of clinical history and skin prick test result.
结局指标
主要结局
Evaluation of T cell responses to SPIREs
时间窗: 2 years
次要结局
- Characterization of the distribution of allergen sensitivity across a broad range of common allergens(2 years)
研究者
研究点 (2)
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