EUCTR2015-001259-63-SE进行中（未招募）1 期
Intralymphatic immunotherapy in increasing doses up to 10 000 SQ-U -a human randomized clinical trial
Department of Clinical Science, Intervention and Technology, Karolinska Institute0 个研究点目标入组 80 人开始时间: 2015年4月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Accepted and signed informed consent.
- •Recently (within 12 months) ended a full 3 year SCIT-program with amelioration of symptoms but not full symptom relief.
- •Accepted and signed informed consent.
- •Moderate to severe seasonal allergic symptoms for grass or birch. Severity levels are assessed by weighing together patient’s medical history, allergen specific S-IgE and skin-prick test reaction. The patient’s subjective description of symptom load during pollen season is most important.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Previously SCIT with total symptom relief.
- •Previously SCIT but no symptom improvement at all.
- •Sensitizations to house dust mite or fur animals, with symptoms.
- •Severe atopic dermatitis.
- •Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- •Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
- •Known autoimmune or collagen disease
- •Hyper-IgE-syndrome
- •Cardiovascular disease
- •Perennial pulmonary disease including asthma
- •Hepatic disease
- •Known renal insufficiency
- •Hematologic disease
- •Chronic infectious disease
- •Any medication with a possible side-effect of interfering with the immune response
- •Previous immuno- or chemotherapy, apart from SCIT
- •Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with ß-blockers)
- •Major metabolic disease
- •Known or suspected allergy to the study product
- •Obesity with BMI > 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
- •Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.
- •Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.
- •Mental incapability of coping with the study
- •Withdrawal of informed consent
研究者
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