An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection
追踪信息 | |||
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首次提交日期 ICMJE | September 4, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | October 2018 | ||
预计主要完成日期 | January 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Profile of patients with chronic HBV infection as measured by a review of concurrent medications, co-morbidities, medical history, staging of liver disease, and additional available clinical results.[ Time Frame: Three year retrospective review. ] Additional results may include AFP, serology results (HBsAg, HBeAg, Anti-HBe, HBV DNA, HBV genotype and precore mutation, HDV) and radiology/histology reports (liver biopsy grade/stage, FibroScan®, MRE, ultrasound). |
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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 | An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection | ||
正式标题 ICMJE | An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection | ||
简要概况 | The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of HBV with TAF and other oral therapies by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to TAF. |
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详细说明 | |||
研究类型 ICMJE | Observational | ||
研究阶段 | |||
研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 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 | Not yet recruiting | ||
预计入组 ICMJE |
500 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | January 2020 | ||
预计主要完成日期 | January 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Male or female patients, age ≥18 years - On a stable antiviral therapy regimen for hepatitis B as determined by treating physician Exclusion - Inability to provide written informed consent/assent - Known coinfection with hepatitis Delta - Known history of Human Immunodeficiency Virus (HIV) | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
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: No 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 | Target PharmaSolutions, Inc. | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | September 2018 | ||
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 |