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CirrhosisPhase 3PRPETNCT02016196

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

A Phase 3 study testing Rifaximin in people with Cirrhosis, run by University Hospital, Toulouse at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cirrhosis
What is being tested?
Rifaximin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
211 participants
Where
13 sitesFrance
Study dates
Sep 2013to Jul 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • CHU Angers

    Angers

  • Hôpital Jean Verdier

    Bondy

  • CHU Bordeaux

    Bordeaux

  • CHRU Lille

    Lille

  • CHU Marseille

    Marseille

  • CHU Nantes

    Nantes

  • CHU Beaujon Clichy

    Paris

  • CHU Saint-Antoine

    Paris

  • Pitié Salpêtrière

    Paris

  • CHU Poitiers

    Poitiers

  • CHU Rennes

    Rennes

  • UHToulouse

    Toulouse, France, 31059

  • CHU Tours

    Tours

Other trials in France

About this study

Official title: Double Blind Randomized Study, Comparing 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 %.

Read the detailed description

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.

Conditions
Cirrhosis
Being tested
Rifaximin, placebo
Keywords
TIPS, portal pressure, rifaximin, overt hepatic encephalopathy, microbiota
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifaximinDrug

    Also called NORMIX

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

    --------------------------------------------------------------------------------

  • placeboDrug

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

Study groups in NCT02016196
Study groupRoleWhat they receive
rifaximinExperimental6 rifaximin caps of 200 mg per day morning and night, during 15 days before TIPS, and after TIPS during 6 months.
Receives: Drug: Rifaximin
placeboPlacebo comparator6 caps placebo morning and night, 15 days before and 6 months after TIPS
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    First episode of overt encephalopathy in patients treated by TIPS

    Measured: 6 months

Secondary outcomes (4)

  1. number of hospitalisation days

    Number and days of hospitalisations for encephalopathy

    Measured: 6 months

  2. Frequency of kidney insufficiency

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

    Measured: 6 months

  3. transplants, deaths

    • number of transplants and deaths

    Measured: 6 months

  4. intestinal microbiota

    Composition of intestinal microbiota in 30 patients (only UHToulouse)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02016196
Sponsor's protocol ID
RC31/12/0551
Acronym
PRPET
Status last verified
Apr 2026
First submitted
13 Dec 2013
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33524293

  • 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.

    PubMed 37467180

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifaximin in people with Cirrhosis, run by University Hospital, Toulouse at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First episode of overt encephalopathy in patients treated by TIPS (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02016196, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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