Hepatitis C Reinfection After Successful Directly Acting Antiviral Treatment: A Belgian Interventional Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy
研究概览
简要总结
The primary aim of this study is to calculate the incidence of HCV reinfection after successful DAA treatment among people who have recently injected drugs. The secondary aim is to identify factors associated with reinfection in this population.
Individuals with active injecting drug abuse with a chronic HCV infection who have achieved end of treatment response (ETR; defined as non-detectable HCV RNA at end of treatment) to any interferon-free DAA combination will be included in this multicenter interventional study.
详细描述
This protocol is an adapted version of the protocol 'Hepatitis C reinfection after successful directly acting antiviral treatment: A North-Atlantic multicenter interventional study'. The investigators will plan this study so that the data are similar to this protocol and results can be compared within this alliance of hepatologists with special interest in care for substance users.
Study schedule: Data collection will be performed according to the study schedule shown in Table 1. Following assessment for SVR12, participants will be followed for 2 years at 6 months' intervals at the discretion of each study site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 18 years or older
- •Injecting drug use within 6 months before start of treatment
- •Achieved an ETR following at least eight weeks of DAA treatment
- •Completed DAA treatment no more than 6 months prior to inclusion
- •Blood sample drawn within 6 months pre-treatment stored at -70° C
排除标准
- •Patients not fulfilling the inclusion criteria.
结局指标
主要结局
Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy
时间窗: up to two years
Number of reinfections with hepatitis C per 100 persons
次要结局
- questionaire to Identify risk factors associated with HCV reinfection(up to 2 years)
- questionnaire to Identify risk factors associated with HCV reinfection(day 1)
研究者
Geert Robaeys
Principal Investigator
Hasselt University