First in Man Trial to Investigate Safety and Efficacy of the New IgE Adsorber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Reduction of IgE concentration in Plasma/Serum
研究概览
简要总结
In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood. In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound. The "cleaned" plasma re-joined with the blood cells is given back to the patient. In total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle. The new adsorber can be safely used in patients. A group of patients with conventional drug treatment and no apheresis treatment serves as control.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Clinically relevant allergy to respiratory allergens confirmed by patient's history, skin-prick testing, IgE serology
- •Allergic asthma (diagnosed by lung specialist)
- •IgE concentration in blood at least 300 kilo Units (kU)/L
排除标准
- •Participation in another trial within 30 days prior to enrolment
- •Gravidity (pregnancy test prior to each treatment cycle)
- •Intake of omalizumab
- •Hepatitis or HIV or malignant disease
- •Specific immunotherapy in the last 6 months
- •Non-allergic asthma
- •Auto-immune diseases
- •Hypocalcaemia
- •Intake of ACE-inhibitors (discontinuation according to half-time before treatment possible)
- •Uncontrolled bleeding and coagulation disorders
- •Severe cardiovascular disease
- •Severe cardiac arrhythmias
- •Severe systemic infection
- •Unability to tolerate therapeutic apheresis procedures (hypersensitivity associated with previous apheresis sessions)
- •Inadequate peripheral venous access
- •Condition in which acute fluid shifts may cause congestive heart failure
- •Established or suspected intra-cranial disease where fluid imbalance or pressure changes could exacerbate the disease
- •Impaired renal function
- •Clinically significant hypotension or borderline hypotension where a further drop in blood pressure could be harmful
结局指标
主要结局
Reduction of IgE concentration in Plasma/Serum
时间窗: Before first treatment (baseline) to after the last of 9 treatments over a time period of 3 months
Decrease in IgE concentrations from before the first apheresis treatment (in the control group the first blood sampling) to after the last apheresis treatment after three months (in the control group last blood sampling after three months)
次要结局
未报告次要终点