EUCTR2018-000868-29-Outside-EU/EEA进行中（未招募）1 期
Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled Phase I Safety Study in Adult and Pediatric Subjects - PEP01.09
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Male or Female age 6 to 50 years at enrollment
- •Physician-diagnosed peanut allergy or convincing history of peanut allergy regardless of the degree of the reaction
- •A positive skin prick test to peanut allergen with a wheal diameter >8 mm AND peanut-specific IgE measured by ImmunoCAP >5kU/L.
- •Use of an effective method of contraception by females of childbearing potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. Women who have had a hysterectomy or tubal ligation at least 6 months prior to the screening visit or who have been post-menopausal for at least 1 year prior to the screening visit are not considered to be of childbearing potential.
- •Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (1994).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participation in a study using an investigational new drug in the last 30 days prior to the screening visit.
- •Participation in any interventional study for the treatment of food allergy in the past 6 months prior to the screening visit.
- •Pregnancy or lactation.
- •Allergy or known hypersensitivity to the Viaskin patch or adhesives.
- •Severe or poorly controlled atopic dermatitis or generalized eczema.
- •FEV1 value <80% predicted or any clinical features of moderate or severe persistent asthma at baseline and treated by doses greater than high daily doses of inhaled corticosteroids (as defined in dosing tables from the 2007 NHLBI guidelines).
- •Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, or burst oral steroid course in the past 6 months, or >1 burst oral steroid course in the past year, prior to the screening visit. Use of oral steroids as described above after the screening visit and before randomization will render the subject non eligible for randomization.
- •Asthma requiring 1 or more hospitalization(s) in the past year or >1 emergency department visit in the past 6 months, prior to the screening visit. Occurrence of asthma in these conditions after the screening visit and before randomization will render the subject non eligible for randomization.
- •Use of omalizumab or immunomodulatory or biologic therapy in the past year prior to the screening visit.
- •Use of nontraditional forms of allergen immunotherapy (such as oral immunotherapy or sublingual immunotherapy) in the past year prior to the screening visit.
- •Use of subcutaneous immunotherapy other than a stable maintenance dose for less than a year prior to the screening visit.
- •Use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers.
- •Inability to discontinue antihistamines for at least 1 week to allow skin testing at the screening visit.
研究者
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