Eligibility criteria {10}
ascites, HBV infection, cirrhosis, HCV infection, NASH, variceal bleeding, T2DM
OESOPHAGEAL VARICES, ASCITES, DECOMPENSATED CIRRHOSIS, EVENT, CIRRHOSIS, ENCEPHALOPATHY, LIVER DISEASE, VARICES
Adult patients with CSPH in compensated cirrhosis, defined by endoscopic proof of gastro-oesophageal varices or preventative endoscopic treatment of oesophageal varices and subsequent HVPG ≥ 10 mmHg, will be included in both studies.In the 1366.0021 trial, eligible patients comprise those with alcohol-related compensated cirrhosis (based on histology or clinical evidence of cirrhosis), aged 18–75 years, who have abstained from significant alcohol misuse/abuse for ≥ 2 months prior to screening and are able to abstain from alcohol throughout the trial (based on investigator judgement; interviews on alcohol consumption will be conducted, and patients will be repeatedly advised to maintain abstinence). If receiving treatment with NSBBs or carvedilol, patients must be on a stable dose for ≥ 1 month prior to screening, with no planned dose change. If receiving treatment with statins, patients must be on a stable dose for ≥ 3 months prior to screening, with no planned dose change. Exclusion criteria include a previous clinically significant decompensation event (ascites extending beyond the perihepatic space, variceal bleeding, encephalopathy), systolic blood pressure of <100 mmHg, diastolic blood pressure of <70 mmHg, Model for End-Stage Liver Disease (MELD) score of >15, a Child–Pugh score of ≥ B8, an alanine or aspartate aminotransferase level of >5 × the upper limit of normal, an estimated glomerular filtration rate (eGFR) of <20 mL/min/1.73 mIn the 1366.0029 trial, eligible patients will comprise those with compensated cirrhosis due to NASH with or without T2DM, HCV infection or HBV infection, based on histology or clinical evidence of cirrhosis. Eligibility criteria, additional or different to the 1366.0021 trial, include the following: patients with HCV must have achieved sustained virological response for ≥ 2 years prior to study inclusion and have no detectable HCV RNA, and patients with HBV infection receiving antiviral therapy must be on a stable dose for ≥ 6 months prior to screening, with no planned dose change and no detectable HBV DNA. Patients will be excluded if they are not receiving adequate treatment for NASH, HBV infection or HCV infection.