NCT03601546已完成不适用
Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2018年9月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Lost to follow-up rate
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies
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
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient is at least 18 years old
- •The patient is HCV RNA positive
排除标准
- 未提供
结局指标
主要结局
Lost to follow-up rate
时间窗: Month 12
Patient inclusion rate
时间窗: End of study: 12 months
Number of patients included/number of eligible patients
Rate of missing data of patient variables
时间窗: Day 0-1
Current treatment, introduction of treatment, viral load, HCV genotype, fibrosis stage, HIV co-infection, drug consumption, alcohol consumption, methadone treatment,
Archival of all signed consent forms
时间窗: End of study: Month 12
次要结局
- initial HCV viral load,(Day 0)
- HIV viral load(Day 0)
- Transaminase levels(Day 0)
- drug and alcohol consumption,(Day 0)
- Lymphocyte T4 level(Day 0)
- Early viral response(Week 4)
- treatment at inclusion(Day 0)
- commencement of treat(Day 1)
- HCV genotype(Day 0)
- Type of treatment(Day 0)
- Access to health cover(Day 0)
- Social-demographic characteristics of patients at inclusion(Day 0)
- Fibrosis stage(Day 0)
- Hepatic ultrasound(Day 0)
- Methadone treatment(Day 0)
- Hepititis B co-infection(Day 0)
- Commencement of treatment(Day 1)
- Treatment side effects(ay)
- Risk factors associated with reinfection(3 months after clearance)
- HIV co-infection(Day 0)
- Sustained viral response(Week 12)
- HCV re-infection(Month 12)
研究者
研究点 (4)
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