NCT05752032进行中（未招募）不适用
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ICM Co. Ltd.
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Incidence of delayed adverse events
研究概览
简要总结
This is an observational study of the long term safety and efficacy of ICM-203.
详细描述
Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous receipt of ICM-203 or matching placebo
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants who previously received placebo in ICM-203 clinical studies
干预措施: Placebo (Drug)
ICM-203
Participants who previously received ICM-203 in ICM-203 clinical studies
干预措施: ICM-203 (Genetic)
结局指标
主要结局
Incidence of delayed adverse events
时间窗: Up to 5 years
次要结局
- Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)(Up to 3 years)
- Joint space width(Up to 3 years)
- Knee pain(Up to 3 years)
- Knee function(Up to 3 years)
- Incidence of total knee replacement(Up to 5 years)
研究者
研究点 (4)
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