Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states.
研究概览
简要总结
Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension.
NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis.
This study intends to demonstrate the desired therapeutic activity (reduction in portal pressure) in a small number of target patients, to assess the safety and tolerability after repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in this population.
详细描述
Brief summary is complete. Study is closed.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female patients of at least 18 years old
- •HVPG > 12 mm Hg in fasting state on Day 1
- •Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs
排除标准
- •Oesophageal bleeding in the previous 30 days
- •Known intolerance to ursodeoxycholic acid or nitrates
- •Liver cancer or liver metastasis from another cancer
- •Portal hypertension secondary to venous thrombosis
- •Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- •Severe liver failure (Child-Pugh C)
研究组 & 干预措施
NCX-1000
Experimental drug under evaluation
干预措施: NCX-1000 (Drug)
Placebo
Placebo powder
干预措施: Placebo (Drug)
结局指标
主要结局
The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states.
时间窗: Day1 and Day 16
The portal pressure, as determined by HVPG, was obtained by subtracting the free hepatic venous pressure from the wedged hepatic venous pressure and rounded to the nearest 0.5 or integer value.The pressures were recorded 3 times for each evaluation and the HVPG value was the mean of the 3 Recordings
次要结局
- Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs)(At various times)
- Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data.(0, 1, 2, 3, and 4 hours after the first 3 doses anf after the last dose)