DRKS00015330尚未招募不适用
Cohort on Hepatitis C Micro-elimination in MSM - NOCO
Zibp GmbH0 个研究点目标入组 200 人开始时间: 2018年11月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Male
入选标准
- •MSM with or without HIV with documented current or spontaneously cleared hepatitis C infection as defined below:
- •a. Documented HCV antibody seroconversion OR
- •b. HCV RNA positive AND
- •c. Prior negative anti-HCV antibody or HCV RNA test within 12 months OR
- •d. rise of any liver transaminases above ULN within the past 12 months with prior normal transaminases during the year before OR
- •e. any ALT elevation and suspected infectious event AND
- •f. exclusion of other causes of acute hepatitis or HCV reinfection after cured or cleared prior HCV infection, defined by
- •a. HCV RNA detectable after SVR12 or spontaneous clearance (two negative HCV RNA measures with an interval of 24 weeks) or
- •b. HCV genotype switch within these timeframes (s.above) and/or
- •c. HCV RNA detectable with phylogenetic proof of reinfection
排除标准
- •1. Patients in whom a time-point of HCV infection cannot be estimated (midpoint between first positive and last negative HCV antibody or RNA (whichever more recent), midpoint between last normal and first raised ALT)
- •2. Inability to provide written informed consent
- •3. Younger than 18 years of age
研究者
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