E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Portal hypertension, liver cirrhosis |
ipertensione portale, cirrosi epatic |
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E.1.1.1 | Medical condition in easily understood language |
aumento della pressione nella vena porta, cirrosi epatica |
increased portal vein pressure, liver cirrhosis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to assess whether the add of Rifaximin in patients with liver cirrhosis and esophageal varices treated with a standard therapy with beta blockers, leads to a significant reduction of portal hypertension
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Diagnosis of liver cirrhosis (based on clinical, biochemical and radiological criteria with or without liver biopsy)
2) Presence of esophageal varices at high risk of bleeding
3) HVPG> 12 mmHg.
4) previous treatment with non-selective beta blockers
5) 19≤age≤75
6) Informed Consent |
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E.4 | Principal exclusion criteria |
1) Patients already treat with beta blockers and then in the secondary prophylaxis for rebleeding
2) Treatment with systemic antibiotics and / or non-absorbable intestinal antibiotics in the previous two weeks
3) Bacterial infection, spontaneous bacterial peritonitis
4) overt hepatic encephalopathy in the last week
5) Gastrointestinal bleeding in act, or in the lastweek
6) active alcoholism or drug abuse in last 3 weeks
7) Acute Alcoholic Hepatitis
8) Hepatocellular carcinoma or other neoplasm
9) significant coronary artery disease (angina NYHA III / IV), congestive heart failure (NYHA III / IV), relevant cardiomyopathy, history of myocardial infarction within the last 12 months
10) Contraindications to the administration of beta blockers; allergy to Rifaximin
11) Pregnancy or lactation
12) Refusal to participate |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of HVPG's levels after 60 days of treatment compared to baseline |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Modifications of gut flora by analyzing the fecal microbiome , Comparison of the Eco-Doppler parameters and HVPG's values, Changes in serum levels of pro-inflammatory cytokines, Adverse Effects |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |