An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
An Exploratory Study to Investigate the Haemodynamic Effects of Serelaxin (RLX030) in Patients With Compensated Cirrhosis and Portal Hypertension
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Edinburgh、英国、EH16 4TJ
- Novartis Investigative Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Study Parts A and B:
-Cirrhosis of alcohol aetiology according to physician's assessment prior to screening.
Part A:
-Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices).
Part B:
- Cirrhosis with TIPSS in situ and PPG>5mmHg.
- Fully functioning TIPSS without variceal filling as confirmed by portography.
Exclusion Criteria:
Study Parts A and B:
- Use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective beta blockers or nitrates) within 1 month prior to screening.
- Decompensated cirrhosis (Child-Pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy) at visit 1.
- Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Part A:
- BMI (weight[kg] / height[m^2]) > 40 kg/m^2.
- Any contraindication to having an MRI scan
Part B:
-Contraindication to catheterization
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Part A: Terlipressin acetate
Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
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IV bolus injection
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实验性的：Part A: Serelaxin (RLX030)
Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.;
duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
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Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours
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实验性的：Part B Serelaxin (RLX030)
The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of Portal pressure gradient (PPG) data acquisition.
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Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))
大体时间：Baseline, 120 min post serelaxin infusion
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The flow is the average flow over the cardiac cycle.
Total renal artery flow = left renal artery flow + right renal artery flow.
These measurements were collected through magnetic resonance angiography (MRA) scans.
Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)
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Baseline, 120 min post serelaxin infusion
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Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)
大体时间：Baseline, 120 min post-infusion start
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Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP). Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion). |
Baseline, 120 min post-infusion start
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))
大体时间：Baseline, 120 min post infusion
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The flow is the average flow over the cardiac cycle.
Total renal artery flow = left renal artery flow + right renal artery flow.
These measurements were collected through magnetic resonance angiography (MRA) scans.
Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)
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Baseline, 120 min post infusion
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Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))
大体时间：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))
大体时间：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))
大体时间：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))
大体时间：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)
大体时间：Baseline, 120 min post infusion
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Portal vein pressure was measured at 15 min intervals (i.e.
prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).
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Baseline, 120 min post infusion
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Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin
大体时间：4 weeks
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This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study.
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4 weeks
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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