NCT02946554已完成2 期
Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure
Cellaion SA20 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2016年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 20
- 主要终点
- Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
研究概览
简要总结
The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Diagnosed cirrhosis
- •Patient with Acute Decompensation of cirrhosis
- •Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L)
- •The INR measurement has to be : 1.2 ≤ INR < 2
排除标准
- •Absence of portal vein flow
- •Known or medical history of thrombotic events
- •Gastrointestinal hemorrhage requiring blood transfusion
- •Variceal bading or sclerosis within 4 weeks before infusion
- •Septic shock or non-controlled bacterial infection
- •Clinical evidence of aspergilus infection.
- •Circulatory failure
- •Respiratory disordered
- •Coagulation disorders defined as INR ≥ 2, Fibrinogen < 100 mg/dL or Platelets < 50.000/mm3
- •MELD score >
- •Major invasive procedure within 4 weeks before infusion
- •Previous organ transplantation and/or ongoing immunosuppressive treatments.
- •Renal failure due to chronic kidney disease.
- •Clinically significant left-right cardiac shunt.
结局指标
主要结局
Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
时间窗: up to 28Day post first infusion day
次要结局
- Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest(3 month and 1 year post first infusion day)
- Efficacy assessed by clinical parameters(28Day, 3 month and 1 year post first infusion day)
- Efficacy assessed by biological parameters(28Day, 3 month and 1 year post first infusion day)
研究者
研究点 (20)
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