NCT04229901终止2 期
Randomized, Placebo-controlled, Double Blind, Multi-centre Phase IIb Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF
Cellaion SA47 个研究点 分布在 14 个国家目标入组 133 人开始时间: 2020年1月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 133
- 试验地点
- 47
- 主要终点
- Survival
研究概览
简要总结
This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults aged between 18 and 75 years old.
- •Have an initial diagnosis of ACLF at the investigational site.
- •Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
- •Have a total bilirubin ≥ 5 mg/dL.
- •Are able to read, understand and give written informed consent.
排除标准
- •Have a MELD-Na score >
- •Have underlying cirrhosis due to biliary disease.
- •Have underlying cirrhosis due to autoimmune hepatitis.
- •Have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
- •Have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
- •Have a complete portal vein thrombosis.
- •Have coagulation disturbances defined as:
- •fibrinogen < 80 mg/dL
- •platelets < 50 x 10³/mm³
- •Are requiring chronic dialysis therapy.
- •Have had a cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the Screening and not considered stabilized by the investigator.
- •Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.
研究组 & 干预措施
HepaStem
Experimental
Patients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 million of cells/kg of total body weight (7 day interval)
干预措施: HepaStem (Drug)
Placebo
Placebo Comparator
Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval)
干预措施: Placebo (Drug)
结局指标
主要结局
Survival
时间窗: Day 90
Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.
次要结局
- Transplant-free survival with MELD-Na score < 15(Day 90)
- Liver transplant-free survival(Day 90)
- Transplant-free survival while free of ACLF(Day 90)
- Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization(up to Day 90)
研究者
研究点 (47)
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