An exploratory haemodynamic study in patients with compensated cirrhosis and portal hypertensio
- Conditions
- Compensated alcohol-related cirrhosis and portal hypertensionMedDRA version: 17.1Level: LLTClassification code 10020786Term: Hypertension portalSystem Organ Class: 100000004871Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2012-000236-26-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
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.
Part A:
-BMI (weight[kg] / height[m]2) > 40 kg/m2.
-Any contraindication to having an MRI scan.
Other protocol inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method