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