NCT05093881招募中不适用
Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Rate of AESI
研究概览
简要总结
This Long-term follow-up is designed to evaluate the safety of patient with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.
详细描述
To evaluate the safety for 60 months after a single dose of Cellgram-LC in patients with alcoholic liver cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who participated in PMC-P-07 clinical trials and received Cellgram-LC
- •Those who voluntarily agreed in writing to participate in this investigation
排除标准
- 未提供
结局指标
主要结局
Rate of AESI
时间窗: For 5 years
death, neoplasms or malignancies in tissues or organs, Immune response including exacerbation or new outbreaks of previous autoimmune diseases, Other delayed AE related to Cellgram LC)
Rate of Liver transplant
时间窗: For 5 years
Liver transplant
次要结局
未报告次要终点
研究者
研究点 (15)
Loading locations...
相似试验
已完成
不适用
Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 StudyAlcoholic Liver CirrhosisNCT02806011Pharmicell Co., Ltd.48
招募中
不适用
Evaluating Alcohol Use in Alcoholic Liver DiseaseAlcoholic Liver DiseaseNCT03267069Nicole T Shen160
进行中（未招募）
4 期
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral SolutionLennox Gastaut SyndromeDravet SyndromeTuberous Sclerosis ComplexNCT05044819Jazz Pharmaceuticals154
已完成
不适用
Boramae Hospital Liver Cirrhosis Patient Cohort StudyHepatocellular CarcinomaLiver CirrhosisNCT01943318Seoul National University Boramae Hospital500
已完成
不适用
Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT ConsortiumAlcoholic HepatitisNCT02172898Indiana University454