Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
Status:
Terminated
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
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.