NCT01867671已完成2 期
Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
National Institute of Allergy and Infectious Diseases (NIAID)9 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2013年8月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 9
- 主要终点
- Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.
详细描述
An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:
- Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.
- Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.
- Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).
- Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
- •Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
- •Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
- •A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
- •Written informed consent from parent/guardian.
排除标准
- •History of severe anaphylaxis with hypotension to peanut;
- •Documented clinical history of allergy to oat;
- •Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
- •Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
- •Active eosinophilic gastrointestinal disease in the past 2 years;
- •Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
- •Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
- •Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
- •Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
- •Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
- •Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
- •Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
- •Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
- •Use of any investigational drug in 90 days prior to visit -1;
- •Plan to use any investigational drug during the study period;
- •The presence of any medical condition that the investigator deems incompatible with participation in the trial.
结局指标
主要结局
Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
时间窗: Week 134
Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.\* \*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.
次要结局
- Count of Participants With Transient Desensitization(Week 134, Week 160)
- Highest Tolerated Cumulative Dose(Week 160)
- Percentage of Tolerant Participants at Week 160(Week 160)
- Percentage of Participants That Withdrew From the Study(Initial Dose Escalation through Week 160 (Tolerance Assessment))
研究者
研究点 (9)
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