CTIS2024-511964-95-00进行中（未招募）1 期
Dapagliflozin in the treatment of decompensated liver cirrhosis: phase IIb randomised, controlled clinical trial - SWEET LIVER
Azienda Ospedale-Universita Padova0 个研究点目标入组 110 人开始时间: 2024年3月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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
- •Age between 18 and 85 years, Diagnosis of liver cirrhosis, documented on the basis of histological examination and/or clinical and/or instrumental examinations (ultrasonography, CT scan or liver elastography > 15 kPa), Liver cirrhosis decompensation (overt hepatic encephalopathy, clinically significant ascites, hemorrhage from esophageal varices) developed within the past 12 months
排除标准
- •Established hypersensitivity to Dapaglifozin, Patient who is a carrier of TIPS, Active therapy for HCV eradication with Direct Antiviral Agents or terminated < 6 months before, Therapy for HBV suppression with nucleoside/nucleotide analogs started < 6 months before, Active alcohol consumption greater than 21 weekly alcohol units, Presence of at least one episode of acute kidney injury (AKI) in the 4 weeks prior to enrollment, Presence of two or more episodes of urinary tract infection in the 12 months prior to enrollment, Presence of >2 episodes of overt hepatic encephalopathy in the 12 months prior to enrollment, Body mass index (BMI) < 20 kg/m^2, History of prior solid organ transplantation, Inclusion in other clinical trials in the month prior to study initiation, Ongoing therapy with SGLT2 inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin, Ertugliflozin etc), Presence of mental incapacity, complete language barrier, poor social support, or other reasons that, in the opinion of the investigator, may preclude the proper conduct of the study, Refusal or inability to sign informed consent and absence of a legal guardian capable of signing consent., Pregnancy or breastfeeding (in the case of women of childbearing age, they will be asked to maintain effective contraception or, alternatively, abstention from sexual intercourse during the observation period), Hepatocarcinoma outside the Milan criteria (a single nodule<5 cm or multiple nodules [maximum 3], the largest of which =3 cm), Active extrahepatic malignancy, Chronic kidney disease with estimated VFG < 30 ml/min/1.73m2, Other known extrahepatic diseases of severe grade (e.g., heart failure NYHA class = 3; COPD GOLD class = 3; psychiatric disorders);, Diagnosis oftype 1 Diabetes Mellitus and/or previous history of diabetic ketoacidosis, Ascites refractory to diuretic therapy according to International Club of Ascites criteria
研究者
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