A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001
研究概览
简要总结
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study
详细描述
The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have been treated with AMG0001 in the AG-CLI-0206 study.
- •Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative.
- •Subjects who have provided a release of information to the sponsor.
排除标准
- •Subjects who were not enrolled in the AGCLI-0206 study.
- •Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG
- •Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative.
- •Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.
结局指标
主要结局
Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001
时间窗: 3 years from the date last subject randomized into AG-CLI-0206 study
A health questionnaire will be used to collect specific information from the subject every 6 months
次要结局
未报告次要终点