NCT02974829Unknown不适用
A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 50
- 主要终点
- Incidence rates of hepatitis B virus (HBV)-related clinical outcome events (COEs), such as non-hepatocellular carcinoma (HCC) HBV progression, HCC, and liver-related mortality, in Studies AI463080 and AI463520 combined, and in Study AI463520.
研究概览
简要总结
The purpose of this study is to conduct an investigator initiated observational study to continue to follow up the China subset of study participants for another 5 years after they complete participation in the REALM Study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients completed REALM Study in China
- •Patients willing to sign the consent to continue anti-viral treatment or post-treatment follow up, and agree his/her legacy data and blood/liver histology samples collected in REALM Study may be used for the analyses planned for this new study.
排除标准
- •Patients who do not provide consent to participate in this study;
- •Patients are formally enrolled into any investigational drug clinical trial after the REALM study.
结局指标
主要结局
Incidence rates of hepatitis B virus (HBV)-related clinical outcome events (COEs), such as non-hepatocellular carcinoma (HCC) HBV progression, HCC, and liver-related mortality, in Studies AI463080 and AI463520 combined, and in Study AI463520.
时间窗: year 5
Treatment patterns in Study AI463520
时间窗: year 5
次要结局
- Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.(year 5)
- Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study(year 5)
- Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520.(year 5)
研究者
研究点 (50)
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