NL-OMON49306已完成3 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
- 3 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Male or female from 1-3 years of age at Visit 1;
- •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;
- •Subject currently following a strict peanut-free diet;
- •Peanut-specific IgE level (ImmunoCAP system) > 0.7 kU/L;
- •Positive peanut SPT with a largest wheal diameter >= 6 mm;
- •Positive DBPCFC to peanut, with symptoms meeting the challenge stopping
- •criteria at an ED <= 300 mg peanut protein.
排除标准
- •Diagnosed asthma not controlled or requiring Step 3 controller treatment or
- •higher (as per Global Initiative for Asthma [GINA] latest guidelines);
- •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 between these episodes, and/or other respiratory symptoms suggesting
- •either undiagnosed asthma or asthma not controlled by asthma treatment (as per
- •GINA latest guidelines).
- •Prior intubation/mechanical ventilation for asthma within one year prior to
- •Peanut allergic subjects presenting a medical history of severe anaphylaxis
- •to peanut will be excluded from this study. Severe anaphylaxis is defined by
- •the Grade 3 of the Anaphylaxis Staging System (see Appendix 4), including
- •- Severe hypoxia, persistent hypotension or more than 20% drop in systolic or
- •diastolic blood pressure, or neurological compromise, or
- •- Cyanosis or SpO2 <= 92% at any stage, confusion, cardiovascular collapse, loss
- •of consciousness, bradychardia, cardiac arrest.
- •- Prior immunotherapy to any food (e.g. oral immunotherapy [except for prior
- •oral immunotherapy of less than 1-month duration which ended at least 3 months
- •before Visit 1], sublingual immunotherapy, specific oral tolerance induction)
- •or other immunotherapy (aeroallergens, venom*);
- •- Generalized severe dermatologic disease (e.g. severe atopic dermatitis,
- •uncontrolled generalized eczema, ichthyosis vulgaris) extending widely on the
- •skin and especially on the back with no intact zones available to apply the
- •Viaskin patches
研究者
相似试验
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)Peanut allergyMedDRA version: 20.1Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870EUCTR2016-003679-23-IEDBV TECHNOLOGIES S.A.400
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)EUCTR2016-003679-23-NLDBV TECHNOLOGIES S.A.400
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)Peanut allergyMedDRA version: 20.1Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870EUCTR2016-003679-23-FRDBV TECHNOLOGIES S.A.400
进行中（未招募）
1 期
Efficacy and safety of Viaskin Peanut in peanut-allergic childreEUCTR2015-002461-37-DEDBV Technologies330
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)Peanut allergyMedDRA version: 20.1Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870EUCTR2016-003679-23-DEDBV TECHNOLOGIES S.A.400