A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Long-term safety assessment
研究概览
简要总结
This is a long-term safety follow-up study of the Phase I/IIa multicenter study of SCM-AGH in subjects with moderate to severe acute pancreatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol SCM-APT2001 (ClinicalTrials.gov ID: NCT04189419) will be eligible for this long-term follow-up protocol.
详细描述
Subjects who meet all eligibility criteria for Long Term Follow-Up(LTFU) study participation at the SCM-APT2001 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who provide written informed consent
- •Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study
排除标准
- 未提供
结局指标
主要结局
Long-term safety assessment
时间窗: Up to 5 Years
Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).
Mortality
时间窗: Up to 5 Years
Ratio of subjects who died during long-term safety follow-up
Ratio of subjects with malignant tumors formed during the long-term safety follow-up period
时间窗: Up to 5 Years
The number, ratio, and number of cases of malignant tumor formation
次要结局
- Number of occurrences of Abnormal, clinically significant in laboratory results(Up to 5 Years)
- Number of occurrences of Abnormal, clinically significant in Vital Signs(Up to 5 Years)