TELMISARTAN for Compensated advanced chronic liver disease | Portal hypertension

Inclusion criteria

• {"criterion_text":"- Patients with compensated advanced chronic liver disease\n- Age ≥18 years and <80 years\n- Child-Pugh stage A or Child-Pugh stage B and model for end-stage liver disease (MELD) ≤15 points at screening\n- Clinically significant portal hypertension (i.e., hepatic venous pressure gradient ≥10 mmHg) based on an adequate hepatic venous pressure gradient tracing\n- Willingness to provide written informed consent and participate in the study"}

Exclusion criteria

• {"criterion_text":"- Age <18 years and ≥80 years\n- Currently decompensated advanced chronic liver disease or history of hepatic decompensation (clinically evident ascites, variceal bleeding, overt hepatic encephalopathy)\n- Child-Pugh stage C or MELD >15 at screening\n- Total bilirubin ≥3 mg/dL or aspartate transaminase/alanine transaminase >5xULN\n- Absence of clinically significant portal hypertension (i.e., hepatic venous pressure gradient <10 mmHg)\n- Cholestatic liver disease (e.g., primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis)\n- Vascular liver disease\n- Occlusive portal vein thrombosis\n- History of liver transplantation\n- History of transjugular intrahepatic portosystemic shunt\n- Hepatocellular carcinoma\n- Intake of renin inhibitors, angiotensin converting enzyme inhibitors, angiotensin II type 1 receptor blockers, or neprilysin inhibitors\n- Severe hypotension (defined as systolic blood pressure <100 mmHg) at screening\n- Uncontrolled/severe arterial hypertension\n- Alcohol consumption/illicit drug use that is expected to interfere with study procedures\n- Initiation of hepatitis C virus or hepatitis B virus treatment within the last year\n- Allergy or hypersensitivity to telmisartan or contraindications for telmisartan\n- Pregnancy, breastfeeding, or unwillingness to utilize a highly effective means of contraception for the duration of the study in women with childbearing potential"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is defined as the difference between HVPG at W12 and baseline.","definition_or_measurement_approach":"Difference in hepatic venous pressure gradient (HVPG) between baseline and Week 12; measured HVPG decrease as main comparison (HVPG measured at baseline and at W12)."}

Secondary endpoints

• {"endpoint_text":"- HVPG response after 12 weeks of treatment is defined as an HVPG decrease ≥10%; i.e., HVPG responders).\n- Change in liver stiffness measurement (in kPa) between W12 and baseline\n- Change in spleen stiffness measurement (in kPa) between W12 and baseline)","definition_or_measurement_approach":"HVPG response: defined as an HVPG decrease ≥10% from baseline at Week 12. Liver and spleen stiffness: change in kPa between baseline and Week 12."}

Austria

Earliest CTIS Part Ii Submission Date

29-11-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

45

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria