跳至主要内容
临床试验/CTRI/2018/12/016505
CTRI/2018/12/016505尚未招募不适用

Registry to Understand Patient characteristics, Treatment Patterns and Therapy Outcomesin Adults with Chronic Hepatitis C Virus Infection

Mylan Laboratories Limited4 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年5月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,000
试验地点
4
主要终点
Prevalence of HCV genotypes, and patterns of anti-HCV treatment strategies in

研究概览

简要总结

Hepatitis C virus (HCV) infectionis a liver disease caused by hepatitis C virus. The global prevalence of HCVinfection has been found to be 2.5% (177.5 million HCV-infected cases). The HCVprevalence rates in Asia, Africa and Europe are 2.9% (26.9 million cases), 2.8%(111.6 million cases), 1.8% (13 million cases), respectively. The HCVprevalence rate in Central Asia and Eastern Europe that encompass the CISregions has been noted to be 5.8%, and 3.1%, respectively. A wide variation hasbeen noted in the prevalence rates of HCV infection, and the distribution ofthe seven genotypes (GT) of HCV among the various regions within eachcontinent. Another epidemiological challenge is the paucity of data related to GTdistribution in some extended regions in Asia, Africa, and some of the CISregions. Several other patient-, government-, payer-, and provider levelbarriers have also been identified in Asia, Africa, and CIS regions, which mayaffect the treatment strategies and subsequent outcomes of HCV management.These barriers are further fueled by the lack of adequate documentation of thetreatment practices and outcomes in these regions.

 The need of the hour is thedevelopment of a data base of the disease and patient characteristics; genotypedistribution; treatment patterns and compliance; and the outcomes of thetreatment of HCV infection in Asia, Africa and CIS regions. An understanding ofall these parameters would help in addressing the potential barriers to HCVmanagement in these regions.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex aged ≥18 years Patients considered eligible for treatment with DAAs, as per the approved prescribing information Patients willing to provide a completed and signed written consent prior to initiation of treatment.

排除标准

  • Concurrent participation in a HCV clinical trial (except trials not testing investigational medicinal products) Patient with a risk of uncertainty regarding returning for follow-up (e.g., patients planning to move or leave the country in a foreseeable future) Pregnant or nursing (lactating) women.

结局指标

主要结局

Prevalence of HCV genotypes, and patterns of anti-HCV treatment strategies in

时间窗: 12 months

different countries

时间窗: 12 months

次要结局

  • Sustained virologic response at 12 and/or 24 weeks after the end of the treatment(with DAA regimens (SVR12 and/or SVR24))

研究者

申办方类型
Pharmaceutical industry-Global

研究点 (4)

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