Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients

A Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Safety and Efficacy of Ifetroban for the Treatment of Portal Hypertension in Cirrhotic Patients

This placebo-controlled study will assess the safety and efficacy of a 90-day course of treatment with ifetroban for portal hypertension in cirrhotic patients

Inclusion Criteria:

• liver cirrhosis
• baseline hepatic venous pressure gradient (HVPG) >= 8 mmHg and <= 18 mmHg
• stable liver function enzymes

Exclusion Criteria:

• portal or splenic vein thrombosis
• Transjugular intrahepatic portosystemic shunt (TIPS) or portocaval shunt
• variceal bleed in last 2 months
• hemodialysis
• Child-Pugh Score >= 12
• Model for End-stage Liver Disease- Sodium score (MELD-Na) >= 20
• Acute kidney injury, Chronic kidney disease and/or Serum Creatinine >= 2.0 mg/dL
• current alcohol consumption > 2 drinks per day
• Platelet count (PLT) < 60 x 10^3/microliter (uL)
• A change in statin therapy in the last 3 months
• Current Hepatitis Virus B or C (HBV or HCV) therapy; or planned initiation of therapy during the treatment period
• Myocardial infarction within 30 days
• History of bleeding diathesis or current (within previous 14 days) or planned use of anticoagulant or antiplatelet drugs including aspirin