Empagliflozin in Cirrhosis (EmC) Safety Study: A safety and pharmacokinetic study

St Vincent's Hospital, Sydney0 个研究点目标入组 23 人开始时间: 2020年10月19日最近更新: 2020年10月26日

适应症

试验速览

暂无简介。

•Inclusion Criteria for liver disease:
•Age: 18 years or older, AND;
•Provision of written, informed consent, AND;
•Known or evident liver cirrhosis. Diagnosis of liver cirrhosis may be based on clinical, radiological, and or histological criteria, including 1 or more of the following:
•a)Previous histologic diagnosis on liver biopsy; or
•b)Clinical evidence of cirrhosis, defined as aspartate aminotransferase > alanine aminotransferase (i.e., AST > ALT), platelet count < 150,000, and nodular liver surface on computed tomography (CT) scan or magnetic resonance imaging (MRI); or
•c)Clinical evidence of significant portal hypertension, based on current or history of gastroesophageal varices on endoscopy, evidence of portosystemic collaterals (on contrast CT or MRI with contrast), and/or presence of ascites; or
•d)Transient elastography consistent with cirrhosis, i.e., result of > 13.0 kPa.

•Patients with kidney disease (creatinine clearance < 30 ml/min) OR;
•Women lactating, pregnant or of childbearing potential and unwilling to avoid becoming pregnant during the study, OR;
•Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study, OR;
•Significant cardiac failure with left ventricular ejection fraction <30%, OR;
•Gastrointestinal surgery that would interfere with medication absorption.

发起方

St Vincent's Hospital, Sydney