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

• Status: Completed
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Ifetroban

Criteria

Inclusion Criteria:

• liver cirrhosis

• baseline HVPG >= 8 mmHg and <= 18 mmHg

• stable liver function enzymes

Exclusion Criteria:

• portal or splenic vein thrombosis

• TIPS or portocaval shunt

• variceal bleed in last 2 months

• hemodialysis

• Child-Pugh Score >= 12

• MELD-Na >= 20

• Acute kidney injury, Chronic kidney disease and/or Serum Creatinine >= 2.0 mg/dL

• current alcohol consumption > 2 drinks per day

• PLT < 60 x 10^3/uL

• A change in statin therapy in the last 3 months

• Current 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