Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and tolerance
研究概览
简要总结
A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis
详细描述
This study was to evaluate the safety, tolerability,efficacy, pharmacokinetics and immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis. The study design consists of two phases: Screening and treatment phase(dose increasing stage).Following the Screening phase, all eligible subjects will be randomized to receive recombinant human albumin injection or HumanAlbumin, study medication in a 3:1 ratio.Dose increasing stage (including 3 dose groups with increasing dose, and each group was set with HumanAlbumin control).The initial dose was 10g. The highest dose group was set at 30g.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age;
- •No less than 45 kg.
- •Diagnosed with ascites due to cirrhosis.
排除标准
- •Allergy to biological products;
- •West-Haven HE ≥ III ;
- •Uncontrolled severe infections;
- •HRS. Serum creatinine (Cr)>2×ULN, or Cr increase>50% during the screening period;
- •Combined with other serious underlying diseases.
- •Organ transplant recipients;
- •Child-bearing females. Pregnancy test positive. Refusing to take contraceptive measures; (8) Participation in other clinical trials. Using study drugs within three month; (9) With the following laboratory test abnormality:
- •PLT<30×109/L, HGB<70 g/L;
- •ALT and (or) AST> 5×ULN, TBIL>3×ULN;
- •Prothrombin activity <40%, PT prolonged>5s;
- •LVEF <50%;
- •The 24h urine volume exceeds 1500 mL/day ;
- •Other subjects by investigator's opinion.
研究组 & 干预措施
active comparator：HumanAlbumin
Participants received HumanAlbumin 10g/d
干预措施: HumanAlbumin (Drug)
Experimental:Recombinant Human Albumin Injection 10g
Participants received Recombinant Human Albumin Injection 10g/d
干预措施: Recombinant Human Albumin Injection (Drug)
Experimental:Recombinant Human Albumin Injection 20g
Participants received Recombinant Human Albumin Injection 20g/d
干预措施: Recombinant Human Albumin Injection (Drug)
Experimental:Recombinant Human Albumin Injection 30g
Participants received Recombinant Human Albumin Injection 30g/d
干预措施: Recombinant Human Albumin Injection (Drug)
结局指标
主要结局
Safety and tolerance
时间窗: Day 1-Day 14（approximately，After the treatment）
Incidence and severity of adverse events
次要结局
- Major efficacy character: Albumin concentration change(Day 1-Day 14（approximately，After the treatment）)
- Efficacy：Ascites regression rate(Day 1-Day 14（approximately，After the treatment）)
- Efficacy：Ascites resolution time(Day 1-Day 14（approximately，After the treatment）)
- Efficacy： HRS (hepato-renal syndrom)(Day 1-Day 14（approximately，After the treatment）)
- Efficacy：Weight(Day 1-Day 14（approximately，After the treatment）)
- Immunogenicity(Day 1-Day 29)
- Efficacy： OHE(overt hepatic encephalopathy)(Day 1-Day 14（approximately，After the treatment）)
- Efficacy： abdominal circumference(Day 1-Day 14（approximately，After the treatment）)
- Pharmacodynamic parameters(Day 1-Day 29)
- PK parameters(Day 1-Day 29)