NCT05900050终止2 期
A Phase 2a, Open-label, Randomized, Controlled, Multi-center Proof of Concept Study to Assess the Efficacy, Safety, and Tolerability of VS-01 on Top of Standard of Care, Compared to Standard of Care Alone, in Adult Patients With Acute-on-chronic Liver Failure (ACLF)
Genfit26 个研究点 分布在 7 个国家目标入组 15 人开始时间: 2023年7月2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
- 15
- 试验地点
- 26
- 主要终点
- Chronic Liver Failure Consortium (CLIF-C) ACLF score at Day 7
研究概览
简要总结
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ACLF Grade 1, 2, or 3a according to European Association for the Study of the Liver (EASL)-CLIF criteria;
- •Onset of ACLF not more than 14 days before Baseline (BL);
- •Presence of ascites requiring diagnostic or therapeutic paracentesis;
- •Patients with dry body weight ≥40 and <140 kg;
- •Written informed consent obtained prior to the start of any study-related procedures.
排除标准
- •Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-C Organ Failure (CLIF-C OF)/CLIF- Sequential Organ Failure Assessment (CLIF-SOFA) scores:
- •Respiratory failure necessitating invasive mechanical ventilation;
- •Coagulation failure (INR > 3.2 or platelet count ≤20 x 109/L);
- •Severe cardiovascular failure requiring the use of high dose vasopressors;
- •ACLF grade 3b: Presence of four or more organ failures as per EASL CLIF criteria;
- •Presence of spontaneous or secondary bacterial peritonitis;
- •Presence of uncontrolled severe infection(with hemodynamic instability or shock);
- •Poorly controlled seizure disorder;
- •Patients with history of upper gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at screening (SCR) or BL;
- •Contraindication for paracentesis;
- •Coagulation disorders such as disseminated intravascular coagulation or hemophilia;
- •Potential or known hypersensitivity to liposomes;
- •Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;
- •Patients after organ transplantation receiving immunosuppressive medication;
- •Any severe disease considered to be potentially detrimental at the discretion of the Principal Investigator. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years or people who inject drugs;
- •Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis);
- •Alfapump® in place to manage ascites;
- •Pregnancy and lactation;
- •Women of child-bearing potential who are not willing to use adequate contraception;
- •Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.
研究组 & 干预措施
SOC (Control Group)
Other
Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF
干预措施: SOC (Control Group) (Other)
VS-01 on top of SOC (Active Treatment Group)
Experimental
Patients randomized to Active Treatment group will receive VS-01 on top of SOC
干预措施: VS-01 on top of SOC (Drug)
结局指标
主要结局
Chronic Liver Failure Consortium (CLIF-C) ACLF score at Day 7
时间窗: 7 days
Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7
时间窗: Day 7
The CLIF-C ACLF score is derived from the CLIF-C organ failure (OF) score. The formula for the CLIF-C ACLF score is CLIF-ACLF = 10\*\[0.33\*CLIF-C OF + 0.04\*Age + 0.63\*Ln(white cell count) -2\]. The CLIF-C ACLF score ranges from 0-100, where a higher score indicated a greater mortality risk.
次要结局
- Transplant-free survival through/at Days 28 and 90(Day 1 through Days 28 and 90, at Day 28 and 90)
- Time to death through Days 28 and 90(Day 1 through Days 28 and 90)
- 28-day and 90-day mortality(At Days 28 and 90)
- Incidence rate, severity, and relationship to VS-01 of adverse drug reactions and serious adverse drug reactions.(Day 0 to Day 90)
- Change in ACLF grade through/at Days 7 and 28(Day 1 through Day 7 and Day 28, at Days 7 and 28)
- Number of Deaths From Day 1 to Day 90(Day 1 to Day 90)
- Number of Deaths From Day 1 to Day 28(Day 1 to Day 28)
- Time to Death Through Day 90(Day 1 to Day 90)
- Number of Participants With ACLF Resolution(Baseline to Day 7 and Day 28)
- Time to ACLF Resolution Through Day 28(Baseline to Day 28)
- Number of Participants With ≥ 1 ACLF Grade Regression(Baseline, Day 7 and Day 28)
- Time to ≥ 1 ACLF Grade Regression Through Day 28(Baseline and Day 28)
- Secondary: Time to Transplant or Death Through Day 90(Day 1 through Day 90)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to Day 90)
研究者
研究点 (26)
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