Safety and efficacy of a human albumin solution with restored structural profile in patients with decompensated cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Primary endpoints of the study will be: - Effective albumin concentration at 1, 3 and 6 months from randomization - Safety of the reHA solution during the 6-month treatment assessed by collecting vital signs, lab parameters and any adverse event, namely: • Percentage of subjects with at least 1 adverse event (AE) or serious adverse event (SAE); • Percentage of subjects with at least 1 Adverse Drug Reaction (ADR); •Total number of AE, SAE and ADR; [truncated text, see protocol for details]
研究概览
简要总结
The primary aim is to assess the impact on effective albumin concentration and the safety of the administration of the reHA solution, as compared to the standard commercial HA solution in patients with decompensated cirrhosis having the indication to long-term albumin treatment
研究设计
- 分配方式
- Randomized
- 主要目的
- Rct
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of liver cirrhosis of any etiology (based on clinical, laboratory, endoscopic and ultrasonographic features); • Patients with grade 2 and 3 ascites according to the criteria of the International Club of Ascites [88] and patients with grade 1 receiving diuretic treatment (at least 200 mg/die of an antialdosteronic drug ± furosemide 25 mg/die); • Patients of both sexes aged between 18 and 85 years; • Written and autonomous informed consent.
排除标准
- •HA infusion in the prior 2 weeks except for paracentesis, spontaneous bacterial peritonitis (SBP) and acute kidney injury-hepatorenal syndrome (AKI-HRS); • Ongoing acute complications of cirrhosis; • Active malignancy except for hepatocellular carcinoma within Milan criteria; • Previous organ transplantation; • Trans jugular intrahepatic portosystemic shunt (TIPS) or Budd-Chiari syndrome; • Antiviral treatment for viral hepatitis started in the last 6 months; • Ongoing alcohol consumption with >21 alcohol U/week or an expected low adherence to protocol; • Chronic organic renal failure stage IV and V; • Chronic heart failure NYHA class III or IV; • Chronic obstructive pulmonary disease GOLD III or IV; • Life expectancy <6 months due to extrahepatic diseases; • Severe psychiatric disorders; • Known or suspected hypersensitivity to HA; • Pregnancy and breast-feeding; • Patients enrolled in other interventional clinical study for the treatment of complication of cirrhosis; • Use of experimental drugs for the last 2 months prior the inclusion in the present study • Hypersensitivity to albumin preparations or to any of the excipients; • Hypersensitivity to Glutathione or any component of the Glutathione solution; • Females of child-bearing potential are excluded unless they meet one of the following criteria: - Post-menopausal defined as no menses for 12 months without an alternative medical cause [89]. If post-menopausal for less than 12 months, a negative pregnancy test is required; - Surgical sterilization for more than one month duration and a negative pregnancy test (permanent sterilization methods include: hysterectomy, bilateral salpingectomy and bilateral oophorectomy) [89]; - Intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test.
结局指标
主要结局
Primary endpoints of the study will be: - Effective albumin concentration at 1, 3 and 6 months from randomization - Safety of the reHA solution during the 6-month treatment assessed by collecting vital signs, lab parameters and any adverse event, namely: • Percentage of subjects with at least 1 adverse event (AE) or serious adverse event (SAE); • Percentage of subjects with at least 1 Adverse Drug Reaction (ADR); •Total number of AE, SAE and ADR; [truncated text, see protocol for details]
Primary endpoints of the study will be: - Effective albumin concentration at 1, 3 and 6 months from randomization - Safety of the reHA solution during the 6-month treatment assessed by collecting vital signs, lab parameters and any adverse event, namely: • Percentage of subjects with at least 1 adverse event (AE) or serious adverse event (SAE); • Percentage of subjects with at least 1 Adverse Drug Reaction (ADR); •Total number of AE, SAE and ADR; [truncated text, see protocol for details]
次要结局
- Signals of efficacy will be searched by comparing the following parameters at 1, 3 and 6 months from randomization: Organ function: Liver function: grade of ascites (International Club of Ascites criteria), grade of HE (West Haven classification and Animal Naming Test), bilirubin and albumin serum levels; Renal function: BUN, serum creatinine, electrolytes, eGFR estimated by the CKD-EPI equation;[truncated text, see protocol for details]
研究者
Paolo Caraceni
Scientific
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico