Effect of administration of Rifaximin on the increased portal pressure of patients with liver cirrhosis and esophageal varices already treated with propranolol

Phase 1

• Conditions: Portal hypertension, liver cirrhosis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-000102-35-IT
• Lead Sponsor: Clinica Medica 5

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-24
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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<br>;Secondary Objective: Not applicable;Primary end point(s): Reduction of HVPG's levels after 60 days of treatment compared to baseline ;Timepoint(s) of evaluation of this end point: Time 0 and after 60 days

Secondary Outcome Measures

Name	Time	Method
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;Timepoint(s) of evaluation of this end point: Time 0 and after 60 days