Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure

Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study

Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension.

NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis.

This study intends to demonstrate the desired therapeutic activity (reduction in portal pressure) in a small number of target patients, to assess the safety and tolerability after repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in this population.

Brief summary is complete. Study is closed.

Inclusion Criteria:

• Male or non-pregnant female patients of at least 18 years old
• HVPG > 12 mm Hg in fasting state on Day 1
• Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs

Exclusion Criteria:

• Oesophageal bleeding in the previous 30 days
• Known intolerance to ursodeoxycholic acid or nitrates
• Liver cancer or liver metastasis from another cancer
• Portal hypertension secondary to venous thrombosis
• Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
• Severe liver failure (Child-Pugh C)