CTIS2022-501006-34-00进行中（未招募）1 期
ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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, Pregnancy, 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
研究者
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