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

Cumberland Pharmaceuticals30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Portal Hypertension Liver Cirrhosis

Interventions

IfetrobanDRUG

thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule

PlaceboDRUG

matched placebo delivered as infusion and oral capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (6)

Tampa General Medical Group

Tampa, Florida, United States

Indiana University

Indianapolis, Indiana, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Safety (Incidence and Severity of Adverse Events)

Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.

Time frame: Through 97 days (90 days treatment and 7 days follow-up)

Safety (Severity of Adverse Events)

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.

Time frame: Through 90 days treatment and 7 days follow-up

Secondary Outcomes

Change in Hepatic Venous Pressure Gradient (HVPG)

The HVPG will be measured through Day 90 and will be compared to baseline

Time frame: Baseline and 90 days

Change in Aspartate Aminotransferase (AST)

AST values through Day 90 will be compared to baseline

Time frame: Baseline and 90 days

Alanine Aminotransferase (ALT)

ALT values through Day 90 will be compared to baseline

Time frame: Baseline and 90 days

Aspartate Aminotransferase/Platelet Ratio (APRI)

The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline

Data from ClinicalTrials.gov

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