EUCTR2015-002105-11-FR进行中（未招募）1 期
A multicenter, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis - not availabe
BioTech Tools S.A.0 个研究点目标入组 654 人开始时间: 2015年8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
- 入组人数
- 654
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
- •The patients are in good physical and mental health according to his/her medical history and vital signs
- •For Females: non-pregnant, non-lactating females with adequate contraception or females unable to bear children (i.e. tubul ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
- •Allergy diagnosis:
- •o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001))
- •o A positive skin prick test (SPT - wheal diameter = 3 mm) to grass pollen mixture, histamine wheal = 3 mm, NaCl control reaction < 2 mm
- •o Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L.
- •o Positive response to CPT with at least 10,000 SQ-E/mL of grass allergens
- •Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
- •For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)
- •For patients with co-sensitisation to birch and parietaria pollen allergens, all of the following criteria must be fulfilled:
- •o The result of the SPT to birch and parietaria pollen has to be less than the result to grass pollen
- •o The specific-IgE level to birch and parietaria pollen allergens has to be less than the specific-IgE level to grass (the CAP RAST class for birch and parietaria has to be at least 1 CAP RAST class less than the CAP RAST class for grass)
- •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 654
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
- •Previous immunotherapy with grass allergens within the last 5 years
- •Ongoing immunotherapy with grass allergens or any other allergens
- •Patients being in any relationship or dependence with the Sponsor, CRO and/or Investigator
- •Inability to understand instructions/study documents
- •Patients with a history of anaphylaxis, including food (e.g. peanut or marine animals) or hymenoptera venom (e.g. bee or wasp stings) or medication (e.g. penicillin)
- •Patients with a history of hypersensitivity to the excipients of the investigational product (gpASIT+TM or placebo)
- •Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014).
- •Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value
- •Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
- •Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed
- •Patients with a history of significant renal disease or chronic hepatic disease
- •Patients with malignant disease
- •Patients with a known severe autoimmune disease
- •Patients with 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.)
- •Patients requiring beta-blockers/acetylcholinesterase inhibitors medication
- •Patients requiring antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
- •Patients requiring anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
- •Patients with any contraindication for the use of adrenaline
- •Patients with a known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
- •Patients who are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry
- •Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
- •Consumption of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in Chapter VIII.6 of the protocol
- •Patients with laboratory values greater than grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit *
- •Unreliable patients including non-compliant patients, 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
- •*Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit will require a retest and only if normalising, the patient will be eligible.
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