EUCTR2010-023176-12-BE进行中（未招募）1 期
Clinical efficacy, immunogenicity, clinical tolerability and assessment of safety of gpASIT+TM administered orally, according to two administration schedules, for the prophylaxis of seasonal grass pollen rhinoconjunctivitis - Not available
Biotech Tools sa0 个研究点目标入组 414 人开始时间: 2010年10月21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
- 414
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
- •Subject has given written informed consent
- •Age between 18 and 50 years
- •The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- •Male or non pregnant, non-lactating female
- •Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
- •Allergy diagnosis:
- •oA medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years
- •oA positive skin prick test (wheal diameter = 3 mm) to grass-pollen mixture
- •oSpecific IgE against grass pollen (IgE > 0.7 kU/l)
- •oAsymptomatic to perennial inhalant allergens
- •Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2008 and who had moderate to severe symptoms during the last two years
- •Subjects with seasonal asthma are allowed to be included
- •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
- •Subjects with current immunotherapy and subjects who underwent an immunotherapy within the last 2 years
- •Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years
- •A history of hypersensitivity to the excipients
- •Subjects with perennial asthma.
- •Subjects requiring control medication against asthma from step 2 according to GINA classification (ref. is made to Appendix 5)
- •Subjects with an VC < 80% and a FEV1 < 70% of predicted value
- •Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
- •Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
- •Subjects symptomatic to perennial inhalant allergens
- •Subjects with a history of hepatic or renal disease
- •Subject with malignant disease, autoimmune disease
- •Any chronic disease, which may impair the subject’s ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…)
- •Subjects requiring beta-blockers medication
- •Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
- •Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
- •Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
- •Use of long-acting antihistamines
- •Subject with febrile illness (> 37.5°C, oral)
- •A known positive serology for HIV-1/2, HBV or HCV
- •Subjects that are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
- •Receipt of blood or a blood derivative in the past 6 months preceding trial entry
- •Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (i.e. OCs, IUD, V-rings and contraceptive implants)
- •Any condition which could be incompatible with protocol understanding and compliance
- •Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
- •Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
- •Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
研究者
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