A Phase II/III Clinical Study of Recombinant Human Albumin Injection for the Treatment of Hypoalbuminemia in Cirrhotic Patients With Ascites
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline in ALB
研究概览
简要总结
This study was a Phase II/III multicenter, blinded, and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and to provide a reference for the design of the Phase III clinical study.
详细描述
This study was a Phase II/III multicenter, blinded, and positive-controlled clinical study with seamless adaptive design. The Phase II clinical study was conducted first, followed by the Phase III clinical study.The Phase II clinical study aimed to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and provide a reference for the design of Phase III clinical study. Dosage: For the 10 g/day rHA injection group, the subjects were administered rHA at a dose of 10 g/day once daily for 14 days. For the 20 g/day rHA injection group, the subjects were administered rHA at a dose of 20 g/day once daily for 7 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects aged 18-65 years (inclusive).
- •Subjects with body weight ≥ 55.0 kg.
- •Subjects who were diagnosed as liver cirrhosis with ascites according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis with Ascites and Related Complications (2017) issued by the Chinese Society of Hepatology CMA, with ascites graded 1-2 at diagnosis or after treatment, and also met the requirement of ALB < 30 g/L (based on test values on Day -14 to Day -3).
- •Subjects who were able to understand and comply with the study procedures, voluntarily participated this study, and had signed the informed consent form (ICF).
排除标准
- •Subjects with a history of allergies to biological products derived from Escherichia coli, yeast, or Chinese hamster ovary (CHO) cells, or blood products such as HSA.
- •Subjects with hepatic encephalopathy of West-Haven HE Grade III or higher.
- •Subjects with uncontrolled infections, such as body temperature > 37.5°C, white blood cell count > 9.5 × 10^9/L, or neutrophil percentage > 80% (including severe abdominal infection, upper respiratory tract infection, lower respiratory tract infection, urinary system infection, etc.).
- •Subjects with a history of hepatorenal syndrome (HRS), or serum creatinine (Cr) > 2 × the upper limit of normal (ULN), or Cr increased by > 50% duringat screening period; or presence of urine protein 2+ or more.
- •Subjects with other severe underlying conditions that, in the opinion of the investigator, affected the participation in this study, including but not limited to malignancies (except for liver cancer patients without portal vein or hepatic vein tumor thrombosis), complicated portal vein thrombosis, non-cirrhotic portal hypertension-related ascites, ischemic heart disease, stroke, chronic obstructive pulmonary disease, and Grade III-IV heart failure, and those with gastrointestinal bleeding who had stopped bleeding for less than 14 days after treatment or failed to stop bleeding after endoscopic variceal ligation.
- •Subjects with organ transplant.
- •Female subjects of childbearing potential who had a positive serum pregnancy test, or subjects refused to use contraceptive measures during the study.
- •Subjects who had participated in other clinical trials and received investigational drugs within 3 months prior to screening.
- •Subjects with abnormal laboratory test values:a.Hematology: platelets (PLT) < 30 × 10^9/L, hemoglobin (HGB) < 70 g/L;b.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × ULN, serum total bilirubin (TBIL) > 3 × ULN;c.Prothrombin activity < 40%, prothrombin time (PT) prolonged by > 5 seconds;d.Left ventricular ejection fraction (LVEF) < 50%.
- •Subjects who were considered inappropriate for participation in the study by the investigator due to other reasons.
结局指标
主要结局
Change from baseline in ALB
时间窗: Day -1/7
The change in ALB was determined by calculating the difference between the value measured after the last dose (immediately after the end of dosing) and the value measured before the first dose (the mean).
次要结局
- Proportion of subjects with serum ALB level reaching 35 g/L at the end of administration(Day 7/14)
- Time taken to attain serum ALB of 35 g/L(Day1- Day7/14)
- Change from baseline in body weight of subjects at the end of administration(Day 7/14)
- Change from baseline in ascites depth of participantsubjects at the end of administration(Day 7/14)
- Change from baseline in abdominal circumference of subjects at the end of administration(Day 7/14)