2022-501006-34-00撤回3 期
ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
Odense University Hospital, European Foundation For The Study Of Chronic Liver Failure6 个研究点 分布在 6 个国家目标入组 180 人开始时间: 2022年9月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) with death, liver transplantation and TIPS as counting and censoring events
研究概览
简要总结
The overall objective is to validate the predictive biomarker of treatment response to human albumin therapy in patients with cirrhosis and ascites
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Decompensated liver cirrhosis defined as Child-Pugh score 7-12
- •Clinical and/or ultrasound evidenced ascites
- •Age above or equal to 18 years
- •At least five days since resolution of a decompensation event or any condition requiring hospitalization
排除标准
- •Patients with acute or subacute liver failure without underlying cirrhosis
- •Refractory ascites as defined by the International Ascites Club
- •Existing TIPS
- •Portal vein thrombosis
- •Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score > 11)
- •Current, planned or previous treatment with direct antiviral agents for HCV in the last six months
- •Contraindications for human albumin infusion (pulmonary oedema, hypersensitivity etc.)
- •Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within BCLC-0 or BCLC-A
- •Hepatic encephalopathy grade III-IV
- •Participation in another study within 3 months prior to screening
- •Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (NYHA above grade II), severe chronic pulmonary disease (GOLD Score above or equal to grade C), severe neurological and psychiatric disorders, pulmonary arterial hypertension)
- •HIV positive or other condition associated with and/or requiring immunosuppression
- •Previous liver or other transplantation
- •Breastfeeding
- •Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent
- •Physician’s denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking)
- •Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy
结局指标
主要结局
Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) with death, liver transplantation and TIPS as counting and censoring events
Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) with death, liver transplantation and TIPS as counting and censoring events
次要结局
- Time-to-first liver-related clinical outcome
- Patients’ quality of life
- Time to first hospital admission (in days)
- Number of intensive care unit admissions
- 6-months survival
- The number of episodes of acute-on-chronic liver failures
- Number of organ failures
- Number of hospital admissions
- Days spent on hospitalization (in days)
- Length of intensive care unit admissions (in days)
- Number of large volume paracentesis
- Analysis of the cost/effectiveness ratio
- Health economic evaluation
- Changes in serum albumin levels
- Number of treatment-related adverse events
- Number of treatment-related serious adverse events
- Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker
- Incidence of refractory ascites
- Incidence of variceal bleeding
- Incidence of spontaneous bacterial peritonitis
- Incidence of infection requiring hospitalization
- Incidence of acute kidney injury >= 1B
- Incidence of hepatorenal syndrome acute kidney injury
- Incidence of overt hepatic encephalopathy
- Incidence of liver transplantation
- Incidence of TIPS insertion
研究者
Nikolaj Torp
Scientific
Odense University Hospital
研究点 (6)
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