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临床试验/NCT01766895
NCT01766895Unknown不适用

Long-term Follow Up of Viral Hepatitis in Uremic Patients in Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,600
试验地点
1
主要终点
seroprevalence of viral hepatitis in uremic patients

研究概览

简要总结

The linkage between viral hepatitis and renal failure is complex. The current study aims to exlore the long-term prevalence of viral hepatitis among uremic patients in Taiwan

详细描述

Patients are prospectively recruited from 15 hemodialysis units including one medical center, 3 satellite hospitals and 11 local clinics in Taiwan. Patients who provided informed consents for blood tests including genetic study related to HCV spontaneous seroclearance are enrolled for analysis. All the eligible subjects are tested for both HCV antibodies (third-generation, enzyme immunoassay; Abbott Laboratories, North Chicago, IL) and hepatitis B surface antigen (HBsAg). HCV RNA is tested by polymerase chain reaction (Cobas Amplicor Hepatitis C Virus Test, V.2.0; Roche Diagnostics, Branchburg, New Jersey, USA; detection limit: 50 IU/ml) twice for at least 6 months apart if anti-HCV is positive to ensure chronicity of HCV infection. HBsAg is quantified with the use of a standard quantitative chemiluminescent microparticle immunoassay (ARCHITECT HBsAg, Abbott Diagnostics). The concentration of HBsAg in the specimen is determined using a previously generated Architect HBsAg calibration curve (range, 0.05-250 IU/mL). Samples with serum HBsAg titer >250 IU/mL were diluted at 1:20 and 1:500 with the Architect HBsAg diluent and retested to expand the upper limit of the dynamic range from 250 to 125,000 IU/mL. Serum HBV DNA is determined by a standardized automated quantitative PCR assay (Cobas Amplicor HBV Monitor; Roche Diagnostics; detection limit 200 copies/ml) if patients are seropositive for HBsAg.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • uremic patients

排除标准

  • 未提供

结局指标

主要结局

seroprevalence of viral hepatitis in uremic patients

时间窗: 10 years

次要结局

  • factors associated with HCV clearance or reappearance(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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