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COMPLETED
NCT02016196
PHASE3

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

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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 %.

Official title: Double Blind Randomized Study, Comparing Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

211

Start Date

2013-09

Completion Date

2017-07

Last Updated

2026-05-06

Healthy Volunteers

No

Conditions

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

Locations (13)

UHToulouse

Toulouse, France, France

CHU Angers

Angers, France

Hôpital Jean Verdier

Bondy, France

CHU Bordeaux

Bordeaux, France

CHRU Lille

Lille, France

CHU Marseille

Marseille, France

CHU Nantes

Nantes, France

CHU Beaujon Clichy

Paris, France

CHU Saint-Antoine

Paris, France

Pitié Salpêtrière

Paris, France

CHU Poitiers

Poitiers, France

CHU Rennes

Rennes, France

CHU Tours

Tours, France