An exploratory study to investigate the haemodynamic effects of serelaxin in patients with compensated cirrhosis and portal hypertension

ovartis Pharma Services AG0 个研究点目标入组 46 人开始时间: 2012年9月13日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Study Parts A and B:
•-Use of any drug to treat portal hypertension (e.g. vasodilators such as nonselective 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.
•-BMI (weight[kg] / height[m]2) > 40 kg/m2.
•-Any contraindication to having an MRI scan.
•Other protocol inclusion/exclusion criteria may apply.

发起方