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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axcan Pharma; Forest Laboratories
• Treatments: Ursodeoxycholic Acid

Criteria

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)