A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
2009年11月12日 更新者：Genentech, Inc.
A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
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.
研究概览
研究类型
介入性
注册 (实际的)
10
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6年 至 75年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1个
|
SC repeating dose
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serious Adverse Events
大体时间：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
|
Through Week 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Food Allergen Exposure, Assessed on Patient-reported Questionnaire
大体时间：Every 4 weeks through Week 52
|
Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction?
(Yes/No)."
|
Every 4 weeks through Week 52
|
|
Food-allergic Reactions As Assessed by the Ewan Scale
大体时间：Through Week 52
|
The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable").
Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator
|
Through Week 52
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
大体时间：Through Week 52
|
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0.
All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
|
Through Week 52
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Dennis Wong, M.D.、Genentech, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年11月1日
初级完成 (实际的)
2008年6月1日
研究注册日期
首次提交
2006年9月26日
首先提交符合 QC 标准的
2006年9月26日
首次发布 (估计)
2006年9月28日
研究记录更新
最后更新发布 (估计)
2009年12月15日
上次提交的符合 QC 标准的更新
2009年11月12日
最后验证
2009年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
omalizumab的临床试验
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