EUCTR2008-006369-10-BE进行中（未招募）不适用
Preliminary assessment of the clinical tolerability, safety and immunogenicity of three different doses of grass pollen-derived peptides for oral use in antigen-specific immunotherapy of seasonal allergic rhinoconjunctivitis - not availbale
BioTech Tools S.A.0 个研究点开始时间: 2009年1月23日最近更新:
试验速览
- 阶段
- 不适用
- 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
- •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
- •Female 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))
- •o A history of 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 (RAST class 2 or IgE > 0.7 kU/l)
- •oAsymptomatic to perennial inhalant allergens.
- •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 or past immunotherapy (any time in the past)
- •Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- •Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
- •Subjects with a history of hepatic or renal disease
- •Subjects symptomatic to perennial inhalant allergens
- •Subject with malignant disease, autoimmune disease
- •Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)
- •Any chronic disease, which may impair the subject’s ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, 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)
- •Subject with febrile illness (> 37.5°C, oral)
- •A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
- •The subject is immunocompromised by medication or illness, has 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
- •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
- •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
- •Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start
- •A history of hypersensitivity to the excipients
- •Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
- •Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
- •Subjects who participated to trial BTT-gpASIT002
研究者
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