NCT00382148已完成2 期
A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Serious Adverse Events
研究概览
简要总结
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.
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
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of last visit (or early termination visit, if applicable) for Study Q2788g
- •Signed Informed Consent Form
- •Use of an effective method of contraception for females of childbearing potential
- •Body weight ≥ 20 kg and ≤ 150 kg
- •IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)
排除标准
- •Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
- •Current participation in another investigational study
- •Pregnancy or lactation
- •History of brittle asthma
- •Aspirin-sensitive asthma
- •Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
- •Have a polymorrphonuclear count <1500/uL
- •Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
- •Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
- •Thrombocytopenia as evidenced by a platelet count < 100,000/uL
- •Any systemic condition requiring regular administration of an immunoglobulin
研究组 & 干预措施
1
Experimental
干预措施: omalizumab (Drug)
结局指标
主要结局
Serious Adverse Events
时间窗: Through Week 52
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
次要结局
- Food Allergen Exposure, Assessed on Patient-reported Questionnaire(Every 4 weeks through Week 52)
- Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs(Through Week 52)
- Food-allergic Reactions As Assessed by the Ewan Scale(Through Week 52)
研究者
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