Overview

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