EUCTR2016-000557-13-DE进行中（未招募）1 期
Assessment of safety and clinical tolerability of hdmASIT+TM administered subcutaneously in house dust mite-induced allergic rhinoconjunctivitis patients. - ABT-hdmASIT001_Phase IIa
ASIT biotech S.A.0 个研究点开始时间: 2016年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 Informed Consent Form by a legally competent patient
- •Female or male patients aged 18–64 years
- •Being in good physical and mental health
- •Normal hepatic and renal function defined as per laboratory values of blood samplings according to local laboratory ranges
- •For females: non-pregnant, non-lactating with adequate contraception or females unable to bear children (i.e. tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
- •Having the diagnosis of allergy based on all the following criteria:
- •A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al 2001))
- •A positive skin prick test (SPT - wheal diameter = 3 mm) to house dust mite Dermatophagoides pteronyssinus, positive control (histamine) wheal = 3 mm, negative control (NaCl) wheal < 2 mm
- •Specific IgE against house dust mite Dermatophagoides pteronyssinus > 0.7 kU/L
- •Positive response to CPT with at least 30,000 SQ-E/mL of Dermatophagoides pteronyssinus solution
- •Having been treated with anti-allergic medication for at least 12 months prior to enrollment
- •For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 = 80% of the patient's reference value (ECSC)
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients must not meet any of the following non-inclusion criteria in order to participate in this study:
- •Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
- •Previous immunotherapy with house dust mite allergens within the last 5 years
- •Ongoing immunotherapy with house dust mite allergens or any other allergens
- •Being in any relationship or dependence with the Sponsor, CRO and/or Investigator
- •Inability to understand instructions/study documents
- •History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
- •History of hypersensitivity to the excipients of the investigational product or placebo
- •Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
- •Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient’s reference value (ECSC)
- •History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
- •Patients symptomatic to any inhaled allergens circulating during the study period (e.g. Mugwort, Ragweed, Alternaria, etc.) documented by history AND sIgE AND SPT
- •Patients symptomatic to any other perennial inhaled allergens (cat, dog) to which are regularly exposed and documented by history AND sIgE AND SPT
- •History of significant renal disease or chronic hepatic disease
- •Malignant active disease (ongoing or in within the past five years)
- •Diagnosed with severe autoimmune disease
- •Any chronic disease which may impair the patient’s ability to participate in the trial (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.)
- •Intake of beta-blockers/acetylcholinesterase inhibitors medication
- •Intake of antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
- •Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
- •Having any contraindication for CPT testing
- •Having any contraindication for the use of adrenaline
- •Known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
- •Female who are pregnant, lactating, or of child-bearing potential and not using adequate contraceptive method
- •Administration of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in the protocol with the exception of routine (previously prescribed) controller medication for asthmatic patients
- •Planned vaccination during the entire study period (e.g. against flu, pneumococcal, etc) – refer to the non authorized mediation section
- •No laboratory values clinically relevant greater than grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit *
- •Patients for who the investigator believes will not comply with the study protocol (patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol)
研究者
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