Patient Registry to Evaluate the Real-world Safety of Ruconest®
赞助:
Pharming Technologies B.V.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | August 9, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | July 16, 2018 | ||
| 预计主要完成日期 | July 16, 2021 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Safety analysis will consist of AEs reported per patient for up to 30 days after each single or repeated dose of Ruconest.[ Time Frame: 3 years ] In addition, extent of exposure to Ruconest and concomitant medications taken for HAE will be summarized. Concomitant medications will be limited to those specifically indicated for treatment AEs or treatment of symptoms of HAE, for example C1-inhibitors, epinephrine, IV fluids, etc. AEs will be summarized as incidence per 10,000 person-days where each patient counts only once for multiple events of the same System Organ Class and preferred terms within the 30-day evaluation period. The person-time duration for each AE for each patient is the time period (in days) between the dose of Ruconest and AE onset. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Patient Registry to Evaluate the Real-world Safety of Ruconest® | ||
| 正式标题 ICMJE | An Observational Patient Registry to Evaluate the Real-world Safety of Ruconest® (C1 Esterase Inhibitor [Recombinant]) for the Treatment of Hereditary Angioedema | ||
| 简要概况 | This is a prospective, real-world, observational patient registry for patients with HAE who are receiving treatment with Ruconest for HAE. |
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| 详细说明 | See below. | ||
| 研究类型 ICMJE | Observational [Patient Registry] | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational [Patient Registry] 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
303 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 16, 2021 | ||
| 预计主要完成日期 | July 16, 2021 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Patient provides informed consent as documented on the Institutional Review Board (IRB) approved informed consent document (ICF). For patients aged between 13 and 17 years old, the method of consent with or without assent will be determined by the IRB. 2. Patient is male or female and at least 13 years of age at the time of providing consent / assent. 3. Patient has been prescribed Ruconest for HAE. Exclusion Criteria: 1. Patient is receiving HAE therapy as part of a clinical trial. | ||
| 性别 |
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| 年龄 | 最小年龄：13 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Pharming Technologies B.V. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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