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Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

NCT02016196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2026-05-06

No results posted yet for this study

Summary

TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.

Conditions

  • Cirrhosis

Interventions

DRUG

Rifaximin

6 rifaximin caps of 200 mg morning and night, 15 days before and 6 months after TIPS \--------------------------------------------------------------------------------

DRUG

placebo

6 placebo caps per day morning and night, during 15 days before TIPS and 6 months after TIPS

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Christophe Bureau, MD PhD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016196 on ClinicalTrials.gov