NCT00086606终止2 期
A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 2
研究概览
简要总结
This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a diagnosis of acute peanut allergy
- •The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms
- •The patient is six to 75 years of age
- •The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC)
- •The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level
- •The patient is able to swallow capsules
排除标准
- •Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines
- •Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
- •Have a history of allergy to wheat protein
- •Have previously been exposed to monoclonal antibody treatment
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
DNS-3379 vs. Placebo in Stroke RehabilitationIschemic StrokeNCT03254160Dart NeuroScience, LLC1
Unknown
2 期
Topical 2% Povidone-Iodine Gel in Verruca VulgarisWartsNCT04253912Veloce BioPharma LLC90
Unknown
2 期
A Phase II, Repeat Single Oral Dose Study of IPED2015 in Healthy Male Subjects With Erectile DysfunctionErectile DysfunctionNCT04969666Initiator Pharma120
已完成
2 期
A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisNCT01225393Genentech, Inc.211
进行中（未招募）
2 期
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk AsthmaAsthmaNCT06676319Sanofi556