EUCTR2011-002317-10-DE进行中（未招募）1 期
Phase II study to assess the tolerability, safety and efficacy of subcutaneous cluster-immunotherapy in patients suffering from house dust mite allergy - Tolerability and efficacy of CLUSTOID mite extract
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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
- •Signed and dated patient's informed consent obtained prior to any study specific examination
- •Female or male patients aged 18-65 at the time of informed consent
- •History of allergic rhinitis / rhinoconjunctivitis due to house dust mites with or without well controlled asthma according to GINA guideline (Global Initiative for Asthma, 2017) for at least 1 year
- •Sensitization to Dermatophagoides pteronyssinus, verified by:
- •- positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and positive (histamine) control = 3 mm) and
- •- Serum specific IgE = 0.7 kU/L (CAP EAST class = 2) and
- •- positive response to nasal provocation with D. pteronyssinus allergen extract
- •Assumed compliance and ability of the patient to follow the instructions of the study staff
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Previous immunotherapy with allergen extract of house dust mites according to the homologous group of the Dermatophagoides genus in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831) within the last 5 years
- •Simultaneous participation in other clinical trials
- •Simultaneous specific immunotherapy with other allergens
- •Usual contraindications for SCIT
- •History of anaphylaxis
- •Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
- •Irreversible secondary disorders of the target organs (e. g. emphysema, bronchoectasis)
- •Completed or ongoing treatment with anti-IgE-antibody
- •Diseases of the immune system including autoimmune and immune deficiencies
- •Severe acute or chronic inflammatory or infectious diseases
- •Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening
- •Systemic and local (eye drops) treatment with beta-blockers
- •Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017).
- •Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma)
- •Relationship or dependence with the sponsor and/or investigator
研究者
相似试验
进行中（未招募）
1 期
Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from grass pollen allergyEUCTR2021-002881-42-DEROXALL Medizin GmbH200
进行中（未招募）
1 期
Phase II study to assess the tolerability, safety and efficacy ofsubcutaneous cluster-immunotherapy in patients suffering from birchpollen allergyEUCTR2011-002296-42-DEROXALL Medizin GmbH165
进行中（未招募）
1 期
Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from birch pollen allergyBirch pollen-related allergic rhinitis / rhino-conjunctivitisMedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855MedDRA version: 20.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853MedDRA version: 20.1Level: LLTClassification code 10066093Term: Birch pollen allergySystem Organ Class: 100000004870EUCTR2011-002319-27-DEROXALL Medizin GmbH165
进行中（未招募）
2 期
A clinical trial to study the effects of two drugs, Folfox and CT-011 in patients with cancer of large intestine.CTRI/2014/08/004922CureTech Ltd171
进行中（未招募）
1 期
Study to evaluate the safety, tolerability and efficacy of CT-011 administered intravenously to patients with metastaticmelanomaEUCTR2011-004501-24-GBCureTech Ltd.100