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

Cumberland Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Portal Hypertension

Liver Cirrhosis

Treatments

Drug: Ifetroban

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02802228

CPI-IFE-005

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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