EUCTR2011-002550-32-NL进行中（未招募）不适用
A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut’s Efficacy and Safety for treating peanut allergy in children and adults. - VIPES
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •1. Peanut-allergic subjects between 6 and 55 years of age, with a well-documented medical history of systemic reactions after ingestion of peanut and currently following a strict peanut-free diet.
- •2. Peanut-specific immunoglobulin E (IgE) level (Phadia CAP-system) > 0.7 kU/L AND a positive peanut SPT with a largest wheal diameter = 8 mm.
- •3. Positive DBPCFC at = 300 mg of peanut proteins: the eliciting dose of peanut proteins during the DBPCFC is capped at 300 mg, i.e. subjects must react to peanut before reaching or at the dose of 300 mg peanut proteins.
- •4. Negative pregnancy test for women of childbearing potential. Females of childbearing age must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
- •5. Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (2005) for subjects 9 years of age and above. For those subjects below 9 years of age who cannot perform spirometry, peak expiratory flow (PEF) will be considered instead.
- •6. Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
- •7. Signed informed consent from adult subjects or parent(s)/guardian(s) of children < 18 years + children’s assent (for children > 7 years or as per country specific regulations).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •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
- •1. Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence) (see Appendix 2: Anaphylaxis Staging System).
- •2. Pregnancy or lactation.
- •3. Forced expiratory volume in one second (FEV1) < 80% of the predicted value at screening (Visit 1) for subjects 9 years of age and above. For subjects below 9 years of age who cannot perform spirometry, the PEF < 80% of predicted will be considered instead.
- •4. Subjects who did not react at or below the dose of 300 mg of peanut proteins during the DBPCFC at screening.
- •5. Subjects allergic to chocolate or who do not consume chocolate.
- •6. Subjects reacting objectively to the placebo formula at screening.
- •7. Severe reaction during the screening food challenge, defined as need for intubation, hypotension persisting after epinephrine administration, or the need for more than two doses of epinephrine.
- •8. Subjects with symptomatic allergy to pollens whose symptoms during the corresponding pollen season might interfere with the recording of symptoms during the DBPCFC, if the DBPCFC is conducted during the pollen season. The Investigator will have to ensure that the period for conducting the DBPCFC for such a subject will be outside of the pollen season.
- •9. Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges.
- •10. Subjects treated with systemic long-acting corticosteroids (depot corticosteroids) within 12 weeks prior to Visit 1 and/or systemic short-acting corticosteroid within 4 weeks prior to Visit 1 or any systemic corticosteroid at screening.
- •11. Subjects with asthma defined as follows:
- •a. uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled ß2-agonists (See Appendix 5: dosages of inhaled corticosteroids);
- •b.at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months;
- •c.prior intubation for asthma in the past two years.
- •12. Subjects on ß-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- •13. Subjects undergoing any type of immunotherapy to any food (oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) within one year prior to Visit 1.
- •14. Subjects presently on aeroallergen immunotherapy and unwilling or unable to discontinue.
- •15. Subjects currently treated with anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy within one year prior to Visit 1.
- •16. Subjects suffering from generalized dermatologic diseases (e.g. severe atopic dermatitis, uncontrolled generalized eczema, keratosis pilaris, ichthyosis vulgaris) with no intact skin zones to apply the Viaskins.
- •17. Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of a food challenge.
- •18. Past or current disease(s), which in the opinion of the Investigator or the Sponsor, may affect the subject’s participation in this study, including but not limited to
研究者
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