NCT05474781招募中不适用
Micro-elimination of HCV Infection Among People Who Use Drug (PWUD) in British.Columbia: A Comprehensive, Multidisciplinary, Scalable Programmatic Approach
Vancouver Infectious Diseases Centre1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年2月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The proportion of individuals enrolled in the study who initiate HCV treatment
研究概览
简要总结
Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to review, sign and date the IRB/IEC approved informed consent form
- •Age ≥19 years
- •Documented HCV RNA positive for 6 months or more, with any HCV genotype
- •Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program
排除标准
- •Previous DAA-based HCV treatment
- •Pregnant or breast-feeding
- •Indications of decompensated liver disease
- •Diagnosis of active hepatocellular carcinoma
- •Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
- •Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
- •Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment
结局指标
主要结局
The proportion of individuals enrolled in the study who initiate HCV treatment
时间窗: 60 months
次要结局
- The proportion of individuals enrolled in the study who achieve sustained virologic response(72 months)
研究者
研究点 (1)
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