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

Phase 2

Completed

Brief 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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)
Ifetroban	Ifetroban	90 day course of oral ifetroban following intravenous loading dose

Primary Outcome Measures

Name	Time	Method
Safety (Incidence and Severity of Adverse Events)	Through 97 days (90 days treatment and 7 days follow-up)	Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.
Safety (Severity of Adverse Events)	Through 90 days treatment and 7 days follow-up	The severity of each event is reported by the investigator according to the following protocol/CTCAE definitions: Grade 1-Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2-Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3-Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4-Life-threatening consequences; urgent intervention indicated; Grade 5-Death related to adverse event.

Secondary Outcome Measures

Name	Time	Method
Alanine Aminotransferase (ALT)	Baseline and 90 days	ALT values through Day 90 will be compared to baseline
Aspartate Aminotransferase/Platelet Ratio (APRI)	Baseline and 90 days	The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline
Variceal Bleeds (Occurrence of Variceal Bleeds)	Through Day 97	The number of variceal bleeds during the treatment and follow-up periods will be evaluated
Change in Aspartate Aminotransferase (AST)	Baseline and 90 days	AST values through Day 90 will be compared to baseline
Change in Hepatic Venous Pressure Gradient (HVPG)	Baseline and 90 days	The HVPG will be measured through Day 90 and will be compared to baseline

Locations (6): Tampa General Medical Group
🇺🇸
Tampa, Florida, United States
The Ohio State University Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
Baylor University Medical Center
🇺🇸
Dallas, Texas, United States
Virginia Commonwealth University Medical Center
🇺🇸
Richmond, Virginia, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States