NCT03963921已完成1 期
Multicenter, Open-label, Safety and Tolerability Study of Ascending Doses of HepaStem in Patients With Cirrhotic and Pre-cirrhotic Non-alcoholic Steato-hepatitis (NASH)
Cellaion SA13 个研究点 分布在 4 个国家目标入组 23 人开始时间: 2019年4月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 13
- 主要终点
- Incidence of Adverse Event
研究概览
简要总结
Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine the safety and tolerability of ascending single and repeated doses of HepaStem administered to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)
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
- •Able and willing to provide written informed consent and comply with the requirements of this study protocol
- •Age 18 to 70-years old, inclusive
- •Proven diagnosis of NASH based on histological evidence from biopsy performed within 6 months for F3 patients and within 2 years for F4 patients prior to Screening If no biopsy is available within these time windows, a biopsy should be performed at Screening NB: For F4 patients for whom the biopsy cannot confirm the diagnosis of NASH, any other causes of underlying liver diseases should be excluded
排除标准
- •Alcoholic liver disease or alcohol consumption exceeding the daily intake of 140g/w (two doses) for women and of 210g/w (three doses) for men
- •Other causes of liver disease including, but not limited to, alcoholic liver disease, active hepatitis B (HbsAg+), hepatitis C (PCR positive), autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, and alpha-1-antitryspin deficiency based on medical history and/ or clinical and biological assessment
- •Recent recurrent or ongoing thrombotic or bleeding events within 3 months prior the screening
- •Patients considered at persistent risk of thrombosis or bleeding at the time of screening
- •Patients with high risk of Gastro intestinal bleeding at time of the screening.
- •Cerebrovascular, myocardial, or limb arterial thrombotic event within 12 months prior to the screening and/or not considered stabilized by the investigator
- •Bariatric surgery within 1 year prior to the screening
- •Coagulation disturbances defined as (Drolz et al. 2016, Nadim et al. 2016, Stravitz et al. 2018, Green et al. 2018): fibrinogen at < 80 mg/dL and/or platelets at < 40 x 10³/mm3
- •Severe hepatic encephalopathy (defined by West Haven grade > 2)
- •Acute Decompensation of cirrhosis with Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score > 60
- •Acute on Chronic liver failure (ACLF) grade 1, 2 ,3
- •MELD score > 20
- •Child Pugh score ≥ C
研究组 & 干预措施
F4 patient population
Experimental
A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner:
干预措施: HepaStem (Drug)
F3 patient population
Experimental
A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner:
干预措施: HepaStem (Drug)
结局指标
主要结局
Incidence of Adverse Event
时间窗: up to Day 28
Safety and Tolerability
次要结局
未报告次要终点
研究者
研究点 (13)
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