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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety (Incidence and Severity of Adverse Events)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver cirrhosis
- •baseline hepatic venous pressure gradient (HVPG) >= 8 mmHg and <= 18 mmHg
- •stable liver function enzymes
排除标准
- •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
研究组 & 干预措施
Ifetroban
90 day course of oral ifetroban following intravenous loading dose
干预措施: Ifetroban (Drug)
Placebo
90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety (Incidence and Severity of Adverse Events)
时间窗: 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)
时间窗: 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.
次要结局
- 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)