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

Effect of administration "add on" of Rifaximin on portal hypertension of patients with liver cirrhosis and esophageal varices in standard therapy with propranolol - ERASE study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000102-35-IT

Enrollment

Registered

2014-10-24

Start date

2014-12-19

Completion date

Unknown

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal hypertension, liver cirrhosis

Interventions

Trade Name: Tixteller Product Name: Tixteller Product Code: A07AA11 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;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	—

Measure

Time frame

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 ;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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactClinica Medica 5

Department of Medicine DIMED

webmaster.medicinadimed@unipd.it00390498212927

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026