Effect of Administration of Rifaximin on the Portal Pressure of Patients With Liver Cirrhosis and Esophageal Varices

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova; University of Padua
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Diagnosis of liver cirrhosis (based on clinical, biochemical and radiological criteria with or without liver biopsy)

• Presence of esophageal varices at high risk of bleeding

• Hepatic Venous Pressure Gradient > 12 mmHg.

• 19≤ age ≤75

• Informed Consent

Exclusion Criteria:

• Patients already treated with beta blockers

• Treatment with systemic antibiotics and/or non-absorbable intestinal antibiotics in the previous two weeks

• Bacterial infection, spontaneous bacterial peritonitis

• overt hepatic encephalopathy in the last week

• active gastrointestinal bleeding, or in the last week

• active alcoholism or drug abuse in last 3 weeks

• Acute Alcoholic Hepatitis

• Hepatocellular carcinoma or other neoplasm

• significant coronary artery disease (angina NYHA III/IV), congestive heart failure (NYHA III/IV), relevant cardiomyopathy, history of myocardial infarct within the last 12 months

• Contraindications to the administration of beta blockers; allergy to Rifaximin

• Pregnancy or breastfeeding

• Refusal to participate