A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 18
- 主要终点
- To evaluate the durability of effect of imdusiran on HBV parameters
研究概览
简要总结
This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study [EOS] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have participated in a prior imdusiran clinical trial,
- •Have discontinued NA therapy in that trial and remain off NA therapy,
- •Have completed less than 3 years of follow-up visits after NA discontinuation in the parent study.
- •Have the ability to review and provide signed informed consent which includes compliance with all protocol-specified visit schedules and requirements.
排除标准
- •Not applicable
结局指标
主要结局
To evaluate the durability of effect of imdusiran on HBV parameters
时间窗: Up to 96 weeks
Proportion of subjects who restart NA therapy, if applicable
次要结局
未报告次要终点