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
Overview
- Phase
- Phase 2
- Intervention
- Ifetroban
- Conditions
- Portal Hypertension
- Sponsor
- Cumberland Pharmaceuticals
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Safety (Incidence and Severity of Adverse Events)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Ifetroban
90 day course of oral ifetroban following intravenous loading dose
Intervention: Ifetroban
Placebo
90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)
Intervention: Placebo
Outcomes
Primary Outcomes
Safety (Incidence and Severity of Adverse Events)
Time Frame: 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)
Time Frame: 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 Outcomes
- Alanine Aminotransferase (ALT)(Baseline and 90 days)
- Aspartate Aminotransferase/Platelet Ratio (APRI)(Baseline and 90 days)
- Variceal Bleeds (Occurrence of Variceal Bleeds)(Through Day 97)
- Change in Aspartate Aminotransferase (AST)(Baseline and 90 days)
- Change in Hepatic Venous Pressure Gradient (HVPG)(Baseline and 90 days)