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CirrhosisPhase 3ProPILARifaxNCT03069131

Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites

A Phase 3 study testing Rifaximin in people with Cirrhosis and Ascites, run by Centre Hospitalier Universitaire de Besancon at 18 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

We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in 'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month survival. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cirrhosis, Ascites, Peritonitis
What is being tested?
Rifaximin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
18 sitesFrance
Study dates
5 Jun 2018to 20 Mar 2023
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 diagnosed on clinical, radiological and/or histological findings
  • Patients with large ascites (i.e., grade 3 ascites requiring paracentesis). Patients with grade 2 ascites are also authorized.
  • Ascites with a low protein level in ascitic fluid (< 15 g/L) with one of the following three conditions:
  • impaired renal function defined by serum creatinine ≥ 106 mmol/L, uremia ≥ 9 mmol/L or serum sodium ≤ 130 mmol/L), or
  • severe liver impairment defined by Child-Pugh score ≥ 9 with serum total bilirubin levels ≥ 51 mmol/L.
  • severe liver impairment defined by Child-Pugh C
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  • Patient who signed an informed consent form
  • Patient with a social security system
  • Woman must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the study if childbearing potential.
  • Patients who needs a TIPS if the procedure is performed 3 months or more following the randomization
  • Patients with severe alcoholic hepatitis can be considered for inclusion if the MELD score < 30 and the Maddrey Discriminant Function < 60 providing that the patient is not infected (and consequently, will not receive antibiotics) and has not yet received corticosteroid (if necessary). Patients not responding to corticosteroid at day 7 (according to the Lille score) could be include after a wash-out of steroids for a period of 7 days.

Who cannot join

  • Pregnant woman or breastfeeding
  • Vulnerable person regarding french law
  • Individual under legal protection measure
  • Individual unable to exprim his/her consent
  • Person under 18 years of age and over 80 years of age
  • Transplanted patients, HIV infection (or patients who deny HIV serology) or immunosuppressive therapy (including patients under corticosteroids for severe alcoholic hepatitis if the patients respond to steroids with improvement of liver function)
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  • Patients with a liver transplant project and an estimated waiting time for liver transplantation of 3 months or less
  • Past SBP or any present bacterial infection
  • Patient who have received a TIPS procedure before rhe randomization
  • Patients with an alfapump
  • Patient receiving antibiotics (including rifaximin) in the 7 days preceding the inclusion in this study exept for patients participating to the microbiota study (15 days).
  • Hypersensitivity to rifaximin, derivatives of rifamycin or one of the constituents of the preparation
  • Hepatocellular carcinoma outside the Milan criteria, other cancer at a palliative stage
  • Any clinical situation with a very low short-terme prognosis (other than cirrhosis), i.e. a survival estimated lower than one month
  • Gastrointestinal bleeding within 7 days
  • Intestinal obstruction
  • Grade 3 hepatic encephalopathy (HE) during the previous 6 months before randomization
  • Chronic heart failure (stage III or IV of the New York Heart Association [NYHA] Functional Classification
  • Patient judged as noncompliant
  • Patients who cannot receive a clear information and who have no trusted relatives
  • Patient who refuses the participation agreement by signing the information form and consent as defined in the protocol.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CHU Amiens

    Amiens, 80054

  • CHU d'Angers

    Angers

  • CHU de Besançon

    Besançon

  • Hôpital Jean Verdier

    Bondy

  • CHU Caen

    Caen, 14033

  • Hôpital Beaujon

    Clichy

  • CHIC de Créteil

    Créteil

  • CHU Grenoble

    La Tronche, 38700

  • CHRU de Lille

    Lille

  • Hopital de la croix-rousse

    Lyon, 69004

  • CHU Montpellier

    Montpellier, 34295

  • CHU de Nice

    Nice

  • Hôpital Pitié Salpêtrière

    Paris

  • CHU de Reims

    Reims

  • CHU de Rennes

    Rennes

  • CHU Rouen

    Rouen, 76031

  • CHU de Toulouse

    Toulouse

  • CHU Tours

    Tours, 37044

Other trials in France

About this study

Official title: A Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial Comparing Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites : Using or Not Using Rifaximin

We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in 'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month survival.

Being tested
Rifaximin, Placebo
Keywords
primary prophylaxis, rifaximin
Medical subject headings
Fibrosis, Ascites, Peritonitis

What participants receive

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

  • RifaximinDrug

    twice daily administration of 1 tablet containing 550 mg of active rifaximin

  • PlaceboOther

    twice daily administration of 1 rifaximin placebo tablet

Study groups in NCT03069131
Study groupRoleWhat they receive
Active rifaximinExperimentalNot described
Receives: Drug: Rifaximin
Rifaximin placeboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. death

    record of death whatever the cause

    Measured: 12 months

Secondary outcomes (12)

  1. Hospital mortality rate and mortality rate at 3 months

    survival during hospitalization and at 3 months

    Measured: 3 months

  2. Hospital mortality rate and mortality rate at 6 months

    survival during hospitalization and at 6 months

    Measured: 6 months

  3. Incidence of spontaneous bacterial peritonitis (SBP) during follow-up

    Bacterial analysis of ascites

    Measured: 12 months

  4. Incidence of the other complications of liver cirrhosis during follow-up

    complications of liver cirrhosis : SBP, HE, gastrointestinal bleeding and hepatorenal syndrome

    Measured: 12 months

  5. Patient hospitalizations during follow-up

    number of days of hospitalization during 12 months of follow-up

    Measured: 12 months

  6. Quantitative variations of IL-6 in serum between day 1 and day 30

    Dosage of IL-6 in serum at D1 and D30

    Measured: 1 month

  7. Quantitative variations of lipopolysaccharides (LPS) in serum between day 1 and day 30

    Dosage of LPS in serum at D1 and D30

    Measured: 1 month

  8. Quantitative variations of copeptin in serum between day 1 and day 30

    Dosage of copeptin in serum at D1 and D30

    Measured: 1 month

  9. Quantitative variations of CRP in serum between day 1 and day 30

    Dosage of CRP in serum at D1 and D30

    Measured: 1 month

  10. Quantitative variations of von Willebrand Factor antigen in serum between day 1 and day 30

    Dosage of von Willebrand Factor antigen in serum at D1 and D30

    Measured: 1 month

  11. Composition of the intestinal microbiota

    analyzis of microbiota (quantity and quality of main bacterial strains) in 25 patients from arms A and B at day 1, and at months 3, 6, 12 and 18

    Measured: up to 18 months

  12. Safety analysis of the study drug

    Record of adverse events and serious adverse events in each arm

    Measured: 12 months

Timeline

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

  1. First posted3 Mar 2017
  2. Study start5 Jun 2018
  3. Primary completion3 Jun 2022
  4. Study completion20 Mar 2023

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03069131
Sponsor's protocol ID
ProPILA-Rifax
Acronym
ProPILARifax
Status last verified
Jan 2025
First submitted
27 Feb 2017
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thevenot T, Elkrief L, Bureau C, Bardou-Jacquet E, Rosa I, Nguyen-Khac E, Oberti F, Pitta A, Mallet M, Lebosse F, Louvet A, Meunier L, Nahon P, Ollivier-Hourmand I, Anty R, Francoz C, Riachi G, Meunier A, Cervoni JP, Tio G, Muller A, Cure-Martin A, Ladeira R, Clairet AL, Hocquet D, Di Martino V, Weil D, Desmarets M. Effect of rifaximin in patients with severe cirrhosis and ascites: A randomized double-blind placebo-controlled trial. J Hepatol. 2025 Dec;83(6):1320-1327. doi: 10.1016/j.jhep.2025.06.019. Epub 2025 Jul 11.

    PubMed 40653111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifaximin in people with Cirrhosis and Ascites, run by Centre Hospitalier Universitaire de Besancon at 18 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 11 inclusion and 21 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

death (time frame: 12 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 NCT03069131, which also lists 1 linked publication.

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 10 Apr 2025.

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