跳至主要内容
临床试验/NCT01594554
NCT01594554Unknown不适用

A 5-year Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Real World Clinical Practice for Patients of Newly Confirmed HCV Infection in China (2012-2016)

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
HCV RNA level

研究概览

简要总结

A 5-year study to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.

详细描述

A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279). In the AI452-009 study, all patients had a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study (AI452-018, CCgenos follow up phase, ClinicalTrials.gov Identifier: NCT01293279) is to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.

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

  • None. Patients from AI452-009 study who accepted ICF to be follow up

排除标准

  • < 18 years old not Han ethnic Not be willing to be followed up to 5 years

结局指标

主要结局

HCV RNA level

时间窗: 5 years

• HCV RNA level when on HCV treatments

次要结局

  • Subjects ratio of cirrhosis, HCC and death(5 years)
  • Viral genotypes of subjects(5 years)
  • Host genotypes of subjects(5 years)
  • Diabetes status of subjects(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lai Wei

Director of Peking University Hepatology Institute at Peking University People's Hospital

Peking University People's Hospital

研究点 (1)

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