Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.
研究概览
简要总结
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.
详细描述
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. Participants will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit double blind placebo controlled food challenge. At the conclusion of the study, participants will be offered continued maintenance therapy off study in line with current specialty standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-16 years
- •History of immediate hypersensitivity reaction to peanut
- •Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment
- •SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE >0.35 kU/L
排除标准
- •History of life threatening peanut anaphylaxis
- •Asthma requiring more than medium dose ICS
- •Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy
- •Oat allergy
- •Cardiovascular Disease
- •Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers
- •Use of steroid medications in the following manners:
- •Daily oral steroid dosing for greater than 1 month during the past year
- •Burst or steroid course in the past 3 month before inclusion
- •Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration
- •Pregnancy or lactation
- •Eosinophilic Gastrointestinal Disease
- •History of food protein-induced enterocolitis
- •History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator
研究组 & 干预措施
Boiled Peanut Powder
Boiled Peanut Powder
干预措施: Boiled Peanut Powder (Drug)
结局指标
主要结局
Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.
时间窗: 18 weeks
The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval.
次要结局
未报告次要终点
研究者
Alton Melton
Sponsor-Investigator
The Cleveland Clinic