Empagliflozin in Cirrhosis (EmC) Safety Study

Phase 2

• Conditions: cirrhosis; portal hypertension; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620001076965
• Lead Sponsor: St Vincent's Hospital, Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-19
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified