EUCTR2007-006551-39-SE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled dose selection study with two RP 01 formulations evaluating anti-IgE immunotherapy in allergic patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Male
入选标准
- •1.Male patient aged between 18 and 60 years, inclusive.
- •2.Allergy to at least one of the following aero allergens; cat, dog, horse, timothy grass, birch, mugwort, house dust mite and cladosporium herbarum, verified by an elevated specific IgE level (=0,50 kU/l IgE; ImmunoCAP®).
- •3.Mentally competent with the ability to understand and comply with the requirement of the study
- •4.Signed informed consent to participate in the study
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Allergies and Respiratory tract conditions
- •1.Diagnosis of asthma.
- •2.Prior experience of an anaphylactic reaction.
- •Concomitant medication
- •3.Use of systemic corticosteroids within 2 months prior to randomisation.
- •4.Corticosteroids used for inhalation within 1 month prior to randomisation.
- •5.Use of any antibiotics within 1 month prior to randomisation.
- •6.Immunosuppressive treatment received within 1 month prior to randomisation.
- •7.Treatment with omalizumab (Xolair) within 1 year prior to randomization.
- •8.Allergy vaccination therapy (desensitisation immunotherapy) within 10 years prior to randomization.
- •9.Any other vaccination received within 3 months prior to randomisation or scheduled to receive vaccination during the first 20 weeks of the study.
- •Other medical history
- •10.History or evidence of significant cardiovascular, renal, hepatic or endocrine disease
- •11.Other clinical significant findings regarding health status as judged by medical history, physical examination, ECG, vital signs, clinical chemistry/hematology/urinalysis that may interfere with the study treatment.
- •12.Positive test for human immunodeficiency virus (HIV), Hepatitis B surface antigen tests and/or antibodies to Hepatitis C virus. (The patient should have been tested within 3 months prior to randomization.)
- •13.Treatment with an investigational drug within 2 months prior to randomization
- •14.Current alcohol or drug abuse
- •15.Donation of blood, exceeding 450 ml, during the 3 months prior to the first administration of the investigational product.
研究者
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