EUCTR2016-003679-23-IE进行中（未招募）1 期
A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study) - EPITOPE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. Male or female from 1-3 years of age at Visit 1.
- •2. Physician-diagnosed peanut allergy or high suspicion of peanut allergy as assessed by the physician: child presenting signs, symptoms and a medical and/or a family history putting him/her at high risk of having a peanut allergy and/or history of presence of peanut-specific IgE and/or positive SPT.
- •3. Subject currently following a strict peanut-free diet.
- •4.Signed informed consent of parent(s)/guardian(s) of the children aged 1-3 years.
- •5. Peanut-specific immunoglobulin E (IgE) level (ImmunoCAP system) > 0.7 kU/L.
- •6. Positive peanut SPT with a largest wheal diameter = 6 mm.
- •7. Positive DBPCFC to peanut, with symptoms meeting the challenge stopping criteria at an Eliciting Dose (ED) =300 mg peanut protein.
- •8. Parents/guardians and subjects willing to comply with all study requirements during their participation in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 400
- •F.1.2 Adults (18-64 years) no
- •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
- •1. Peanut allergic subjects presenting a medical history of severe
- •anaphylaxis to peanut will be excluded for this study. Severe
- •anaphylaxis is defined by the Grade 3 of the Anaphylaxis Staging System(Appendix 4), including:
- •Severe hypoxia, persistent hypotension or more than 20% drop in
- •blood pressure, neurological compromise, or
- •Cyanosis or SpO2 = 92% at any stage, confusion, cardiovascular
- •collapse, loss of consciousness, bradychardia, cardiac arrest.
- •2. Severe reaction during the entry/screening DBPCFC, defined as any of the following:
- •Need for intubation
- •Hypotension persisting after epinephrine administration
- •Need for three doses or more of systemic epinephrine.
- •3. Subject with reactions to the placebo formula during the screening
- •DBPCFC(with reactions deemed to stopping the challenge).
- •4. Subjects who fail to complete the entry food challenge due to any
- •reason including clear aversion to the food formula matrix,
- •5. Subject with any clinically significant abnormality identified at the
- •time of screening such as major infantile infectious diseases (pox,
- •measles) which in the judgment of the Investigator can preclude safe
- •participation or strict compliance to the protocol procedures. Subjects
- •can be considered for the study after recovery from these diseases.
- •6. Viral upper respiratory infection or gastroenteritis or any severe
- •disease within 7 days of food challenge (challenge must be rescheduled
- •at least after 7 days upon recovery).
- •7. Hypersensitivity to any of the Viaskin® patch components (except to
- •peanut protein), including the adhesive film.
- •8. Hypersensitivity to any component of the food challenge formula
- •(except to peanut protein) or a known history of apple allergy.
- •9. Inability to discontinue short-acting antihistamines or long-acting
- •antihistamines for the minimum wash-out periods required (depending
- •on half-lives and specified in APPENDIX 3) prior to the skin prick testing
- •or the food challenges.
- •10. Diagnosis of asthma that fulfills any of the following criteria:
- •Uncontrolled asthma (as per Global Initiative for Asthma [GINA] latest
- •guidelines; see APPENDIX 8)
- •Asthma requiring controller treatment step 3 or higher (as per GINA
- •latest guidelines: either moderate [double low dose] of inhaled
- •corticosteroid, or association of inhaled corticosteroid with leukotriene
- •receptor antagonist [see APPENDIX 8]. Long acting beta agonists are not recommended below 5 years)
- •History of 2 or more systemic corticoid courses within the 3 previous
- •months prior to Visit 1 or 1 systemic corticoid course within the 4 weeks
- •prior to Visit 1 for treating a diagnosed asthma.
- •Prior intubation/mechanical ventilation for asthma within one year
- •prior to Visit 1. Asthmatic subjects with the following treatment options are eligible:
- •- No controller treatment (GINA Step 1),
- •- Controller treatment monotherapy (GINA Step 2):
- •o with daily or short-term course (intermittent) low dose inhaled
- •corticosteroid,
- •o or with leukotriene receptor antagonist.
- •11. Presence of more than 3 episodes of wheezing in the past year (each lasting more than 10 consecutive days, apart from colds) or presence of respiratory symptoms (wheezing, cough, heavy breathing) between these episodes, and/or other respiratory symptoms suggesting either undiagnosed asthma or asthma not controlled by asthma treatment (as per GINA latest guidelines, see APPENDIX 8).
- •12. Generalized dermatologic disease (e.g. severe atopic dermatitis,
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研究者
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