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临床试验/NCT01474811
NCT01474811已完成不适用

HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.

University of North Carolina, Chapel Hill60 个研究点 分布在 1 个国家目标入组 13,559 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13,559
试验地点
60
主要终点
Sustained virological response (SVR)

研究概览

简要总结

The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.

详细描述

HCV-TARGET is a longitudinal, observational study that will create a carefully maintained research registry of HCV patients treated with antiviral therapies designed to rapidly inform strategies for better management of populations underrepresented in clinical trials, identify and remediate educational gaps relative to treatment guidelines and adverse event management in order to optimize rates of sustained virological response (SVR), and serve as the core resource for important collaborative translational studies utilizing biospecimens and clinical data from diverse patient populations.

HCV-TARGET is a cooperative academic consortium of principal investigators from Clinical and Translational Award (CTSA)-funded academic institutions and community-based sites affiliated with the academic sites in geographic proximity. The Clinical Coordinating Center (CCC) resides at the University of Florida and the Data Coordinating Center (DCC) resides at the University of North Carolina at Chapel Hill.

The HCV-TARGET registry will characterize the population of chronic hepatitis C (HCV) patients who are being treated with antiviral therapies at academic and community sites. Patient characteristics such as age, race, ethnicity, comorbidity, and disease and treatment status will be examined.

HCV-TARGET will also:

  1. Provide baseline and treatment response data that will be used to pre-identify candidates for enrollment in future clinical trials. HCV-TARGET will also develop a well-characterized cohort of protease inhibitor treatment failures to be considered for future trials.
  2. Establish and maintain data, a specimen bank and other resources for ancillary studies of the pathogenesis, diagnosis, natural history and treatment of HCV infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens that contain telaprevir or boceprevir.

排除标准

  • Inability to provide written informed consent.
  • Currently participating in another clinical trial of hepatitis C therapeutics. Studies comparing HCV RNA assays are not considered exclusionary.

结局指标

主要结局

Sustained virological response (SVR)

时间窗: 24 months

The primary outcome measure is the occurence (yes or no) of SVR, defined as undetectable HCV RNA in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various sub-populations enrolled in HCV-TARGET.

次要结局

  • Virological breakthrough(24 months)
  • Treatment persistence(24 months)
  • Management of adverse events(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (60)

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