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Completed

NCT Number: NCT02016196

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

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 %.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UHToulouse, Toulouse, France

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About this study

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 %. Furthermore, the pathogenesis of HE in general but also in patients treated by TIPS is still not well understood. Therefore, there is a real challenge in discovering new molecular mechanisms involved in pathogenesis of OHE as well as new treatment to better prevent the risk of OHE in patients treated by TIPS. Observational and experimental studies suggest a microbiota's role in the mechanism of OHE and recently a non absorbable antibiotic has proven to reduce the risk of recurrence of OHE. However, the effect of this drug for the prevention of a first episode of OHE in patients treated by TIPS is not known. In addition, the mechanisms of the beneficial effect of rifaximin remain poorly understood.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cirrhosis with TIPS for ascit treatment or hydrothorax
  • prevention digestive bleeding follow up portal hypertension -
  • signed consent

Exclusion criteria

  • hepatocellular carcinoma out of Milan criteria or palliative phase cancer
  • Child Pugh score > 12
  • TIPS indicated for other indication than bellow
  • encephalopathy signs : asterixis or confusion
  • Hypersensibility to rifaximin, or derivated of rifamycin
  • Patients treated by same class antibacterial
  • pregnant woman
  • Patient with hepatic transplant

Treatment and study plan

Rifaximin

Drug

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

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Other names: NORMIX

Placebo

Drug

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

Primary outcomes

  1. First episode of overt encephalopathy in patients treated by TIPS

    Time frame: 6 months

    First episode of overt encephalopathy in patients treated by TIPS

Secondary outcomes

  1. number of hospitalisation days

    Time frame: 6 months

    Number and days of hospitalisations for encephalopathy

  2. Frequency of kidney insufficiency

    Time frame: 6 months

    number of digestive bleeding follow up to portal hypertension, number of ascit punctions, frequency kidney insufficiency and hepatocellular carcinoma

  3. transplants, deaths

    Time frame: 6 months

    • number of transplants and deaths

  4. intestinal microbiota

    Time frame: 6 months

    Composition of intestinal microbiota in 30 patients (only UHToulouse)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PRPET

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2013
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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