A Multicenter, Randomized, Controlled, Open-Label Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects With Acute-On-Chronic Liver Failure
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Safety outcome
研究概览
简要总结
This is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with acute-on-chronic liver failure（ACLF）.
Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively.
Phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily.
- •Age: ≥ 18 years and ≤ 65 years.
- •Body weight: ≥ 40kg;
- •Met the criteria of ACLF in the early and middle stages in screening period (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by various inducements, manifested as extreme fatigue, with obvious gastrointestinal symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive deepening of jaundice, serum TBil ≥ 171 μmol/L or increase ≥ 17.1 μmol/L daily or ≥10 × upper limit of normal value; with bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%<PTA ≤ 40% (or 1.5 ≤ INR<2.6), and other reasons excluded.
排除标准
- •Subjects with primary or metastatic liver cancer.
- •Subjects with severe esophageal/gastric varices and high risk of bleeding, with positive red signs, or with previous active bleeding, as indicated by gastroscopy or imaging examination results.
- •Serum creatinine was greater than 132.6 μmol/L.
- •Subjects with serious uncontrolled infections, including sepsis, septic shock, severe pneumonia (refers to the diagnostic criteria of the American Society of Infectious Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal infection (exist Peritonitis manifestations or white blood cells in ascites>0.1 × 10 9/L after reasonable antibiotic treatment), etc;
结局指标
主要结局
Safety outcome
时间窗: From the initiation of treatment until 14 days after the end of study treatment.]
Based on the recorded adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and device deficiencies (such as leakage caused by the inherent quality issues of the plasma bio-purification column), the safety from the start of the study treatment until 14 days after the end of the study treatment was evaluated.（Phase I）
survival rate
时间窗: 12 weeks after the initial treatment]
The survival rate without liver transplantation at 12 weeks after the first treatment.（PhaseⅡ） Absolute change from baseline in the MELD score of subjects at week 4 after the first treatment. （PhaseⅡ）
次要结局
未报告次要终点