NCT02016196

Brief 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 %.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2013

Typical duration for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

December 13, 2013

Last Update Submit

April 29, 2026

Conditions

Cirrhosis

Keywords

TIPSportal pressurerifaximinovert hepatic encephalopathymicrobiota

Outcome Measures

Primary Outcomes (1)

  • First episode of overt encephalopathy in patients treated by TIPS

    First episode of overt encephalopathy in patients treated by TIPS

    6 months

Secondary Outcomes (4)

  • number of hospitalisation days

    6 months

  • Frequency of kidney insufficiency

    6 months

  • transplants, deaths

    6 months

  • intestinal microbiota

    6 months

Study Arms (2)

rifaximin

EXPERIMENTAL

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

Drug: Rifaximin

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

RifaximinDRUG

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

Also known as: NORMIX
rifaximin
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

UHToulouse

Toulouse, France, 31059, France

Location

CHU Angers

Angers, France

Location

Hôpital Jean Verdier

Bondy, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHRU Lille

Lille, France

Location

CHU Marseille

Marseille, France

Location

CHU Nantes

Nantes, France

Location

CHU Beaujon Clichy

Paris, France

Location

CHU Saint-Antoine

Paris, France

Location

Pitié Salpêtrière

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, France

Location

CHU Tours

Tours, France

Location

Related Publications (2)

  • Bureau C, Thabut D, Jezequel C, Archambeaud I, D'Alteroche L, Dharancy S, Borentain P, Oberti F, Plessier A, De Ledinghen V, Ganne-Carrie N, Carbonell N, Rousseau V, Sommet A, Peron JM, Vinel JP. The Use of Rifaximin in the Prevention of Overt Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt : A Randomized Controlled Trial. Ann Intern Med. 2021 May;174(5):633-640. doi: 10.7326/M20-0202. Epub 2021 Feb 2.

    PMID: 33524293RESULT

  • Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

    PMID: 37467180DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Christophe Bureau, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2013

First Posted

December 19, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

FR(13)