NCT07254208Enrolling By Invitation不适用
A Long-term Observational Study in Participants Who Have Received PBGENE-HBV, an In Vivo Gene Editing Investigational Product, in a Prior Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Safety to assess frequency, severity, and outcome of delayed adverse events
研究概览
简要总结
Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.
详细描述
This is a LTFU observational study designed to evaluate the safety of PBGENE-HBV in participants previously exposed to PBGENE-HBV. This study protocol does not include administration of PBGENE-HBV.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has received at least 1 dose of PBGENE-HBV investigational product in a prior clinical study
- •Participant, or their legally authorized representative, has provided signed informed consent.
排除标准
- 未提供
结局指标
主要结局
Safety to assess frequency, severity, and outcome of delayed adverse events
时间窗: 15 years
Delayed adverse events
次要结局
未报告次要终点
研究者
研究点 (4)
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