AzTrials
AzTrials

Hepatic EncephalopathyPhase 3RED-C-3132NCT05297448

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis

A Phase 3 study testing Rifaximin SSD in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 188 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hepatic Encephalopathy
What is being tested?
Rifaximin SSD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
466 participants
Where
188 sitesin 17 countries
Study dates
3 Aug 2022to Jan 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
  • Conn (West Haven Criteria) score of < 2.
  • Mini-Mental State Examination (MMSE) score > 24 at screening.
  • ≥ 18 and ≤ 85 years of age.

Who cannot join

  • Active COVID-19 that is unresolved
  • History of SBP
  • History of EVB or AKI-HRS within 6 months
  • History of OHE episode (Conn score ≥ 2)

Trial locations and contacts

188 sites in 17 countries.

188 sites in 17 countries

United States90 sites

  • Bausch Site 581

    Allentown, Pennsylvania, 18104

  • Bausch Site 427

    Asheville, North Carolina, 28801

  • Bausch Site 550

    Bakersfield, California, 93309

  • Bausch Site 402

    Burlington, Vermont, 05401

  • Bausch Site 445

    Chandler, Arizona, 85224

  • Bausch Site 423

    Chattanooga, Tennessee, 37421

  • Bausch Site 434

    Chattanooga, Tennessee, 37421

  • Bausch Site 575

    Colorado Springs, Colorado, 80907

  • Bausch Site 599

    Columbia, South Carolina, 29204

  • Bausch Site 415

    Coronado, California, 92118

  • Bausch Site 585

    Covina, California, 91722

  • Bausch Site 585

    Covina, California, 91723

  • Bausch Site 406

    Dallas, Texas, 75390

  • Bausch Site 410

    Dayton, Ohio, 45414

  • Bausch Site 519

    Denison, Texas, 75929

  • Bausch Site 425

    Doral, Florida, 33122

  • Bausch Site 436

    East Syracuse, New York, 13057

  • Bausch Site 598

    Florham Park, New Jersey, 07932

  • Bausch Site 463

    Flowood, Mississippi, 39232

  • Bausch Site 597

    Freehold, New Jersey, 07728

  • Bausch Site 592

    Fresno, California, 93720

  • Bausch Site 583

    Greenbelt, Maryland, 20770

  • Bausch Site 475

    Gurnee, Illinois, 60031

  • Bausch Site 400

    Harrisburg, Pennsylvania, 17110

  • Bausch Site 579

    Hermitage, Tennessee, 37076

  • Bausch Site 449

    Hialeah, Florida, 33012

  • Bausch Site 558

    Hialeah, Florida, 33012

  • Bausch Site 418

    Hialeah, Florida, 33013

  • Bausch Site 468

    Hollywood, Florida, 33024

  • Bausch Site 591

    Homewood, Alabama, 35209

  • Bausch Site 437

    Houston, Texas, 77074

  • Bausch Site 447

    Humble, Texas, 77346

  • Bausch Site 460

    Jefferson City, Missouri, 65109

  • Bausch Site 457

    Lafayette, Louisiana, 70503

  • Bausch Site 582

    Lancaster, California, 93534

  • Bausch Site 580

    Liberty Township, Ohio, 45044

  • Bausch Site 590

    Long Beach, California, 90808

  • Bausch Site 414

    Los Angeles, California, 90067

  • Bausch Site 577

    Macon, Georgia, 31201

  • Bausch Site 531

    Marrero, Louisiana, 70072

  • Bausch Site 488

    Metairie, Louisiana, 70006

  • Bausch Site 495

    Miami, Florida, 23229

  • Bausch Site 543

    Miami, Florida, 33032

  • Bausch Site 479

    Miami, Florida, 33125

  • Bausch Site 428

    Miami, Florida, 33126

  • Bausch Site 470

    Miami, Florida, 33134

  • Bausch Site 486

    Miami, Florida, 33144

  • Bausch Site 552

    Miami, Florida, 33165

  • Bausch Site 594

    Miami, Florida, 33165

  • Bausch Site 456

    Miami, Florida, 33175

  • Bausch Site 458

    Miami, Florida, 33176

  • Bausch Site 435

    Miami, Florida, 33186

  • Bausch Site 452

    Miami Lakes, Florida, 33016

  • Bausch Site 494

    Monroe, North Carolina, 28112

  • Bausch Site 413

    New Orleans, Louisiana, 70125

  • Bausch Site 559

    Norfolk, Virginia, 23502

  • Bausch Site 431/443

    Ocala, Florida, 34471

  • Bausch Site 450

    Ocala, Florida, 34471

  • Bausch Site 446

    Ocoee, Florida, 34761

  • Bausch Site 405

    Orange, California, 92868

  • Bausch Site 421

    Orange City, Florida, 32763

  • Bausch Site 596

    Orlando, Florida, 32808

  • Bausch Site 537

    Palmetto Bay, Florida, 33157

  • Bausch Site 576

    Philadelphia, Pennsylvania, 19104

  • Bausch Site 407

    Port Orange, Florida, 32127

  • Bausch Site 484

    Providence, Rhode Island, 02905

  • Bausch Site 424

    Richmond, Virginia, 23226

  • Bausch Site 490

    Richmond, Virginia, 23229

  • Bausch Site 595

    Richmond, Virginia, 23236

  • Bausch Site 404

    Roanoke, Virginia, 24014

  • Bausch Site 448

    San Marcos, Texas, 78130

  • Bausch Site 442

    Shreveport, Louisiana, 71105

  • Bausch Site 422

    Smithfield, North Carolina, 27577

  • Bausch Site 588

    South Bend, Indiana, 46635

  • Bausch Site 411

    Sparta, New Jersey, 07871

  • Bausch Site 403

    Springboro, Ohio, 45066

  • Bausch Site 480

    Summerville, South Carolina, 29486

  • Bausch Site 453

    Sun City, Arizona, 85351

  • Bausch Site 401

    The Bronx, New York, 10467

  • Bausch Site 455

    Toms River, New Jersey, 08755

  • Bausch Site 524

    Topeka, Kansas, 66606

  • Bausch Site 587

    Tucson, Arizona, 85715

  • Bausch Site 600

    Union City, Tennessee, 38261

  • Bausch Site 482

    Valencia, California, 91355

  • Bausch Site 409

    Waco, Texas, 76712

  • Bausch Site 454

    Wellington, Florida, 33467

  • Bausch Site 466

    West Des Moines, Iowa, 50266

  • Bausch Site 472

    Westlake, Ohio, 44145

  • Bausch Site 416

    Wichita Falls, Texas, 76301

  • Bausch Site 429

    Zephyrhills, Florida, 33542

Other trials in United States

South Korea19 sites

  • Bausch Site 759

    Busan, 47392

  • Bausch Site 751

    Busan, 49241

  • Bausch Site 769

    Daegu, 41944

  • Bausch Site 764

    Daegu, 42601

  • Bausch Site 763

    Daejeon, 34943

  • Bausch Site 768

    Gangwon-do, 26426

  • Bausch Site 758

    Goyang-si, 10408

  • Bausch Site 765

    Gyeonggi-do, 15355

  • Bausch Site 754

    Gyeongsang, 50612

  • Bausch Site 770

    Seongnam-si, 13496

  • Bausch Site 757

    Seoul, 013722

  • Bausch Site 766

    Seoul, 01830

  • Bausch Site 752

    Seoul, 03080

  • Bausch Site 762

    Seoul, 03312

  • Bausch Site 760

    Seoul, 06273

  • Bausch Site 753

    Seoul, 06351

  • Bausch Site 767

    Seoul, 06591

  • Bausch Site 755

    Seoul, 08308

  • Bausch Site 761

    Yongin-si, 16995

Other trials in South Korea

France14 sites

  • Bausch Site 804

    Angers, 49100

  • Bausch Site 818

    Belfort, 90015

  • Bausch Site 810

    Besançon, 25000

  • Bausch Site 802

    Clermont-Ferrand, 63003

  • Bausch Site 808

    Limoges, 87042

  • Bausch Site 805

    Lyon, 69004

  • Bausch Site 807

    Nice, 06200

  • Bausch Site 801

    Paris, 75013

  • Bausch Site 817

    Paris, 75014

  • Bausch Site 809

    Pessac, 33604

  • Bausch Site 815

    Rennes, 35033

  • Bausch Site 803

    Toulouse, 31059

  • Bausch Site 813

    Vandœuvre-lès-Nancy, 54500

  • Bausch Site 811

    Villejuif, 94804

Other trials in France

Canada12 sites

  • Bausch Site Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • Bausch Site Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Bausch Site Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6

  • Bausch Site University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Bausch Site McMaster University Medical Centre - Hamilton Health Services

    Hamilton, Ontario, L8V 1C3

  • Bausch Site Clinique Medicale L'Actuel

    Montreal, Quebec, H2L 4P9

  • Bausch Site: CHUM Centre de Recherche

    Montreal, Quebec, HSX 0A9

  • Bausch Site 605

    Québec, G1V 4T3

  • Bausch Site Albany Medical Clinic

    Toronto, Ontario, M3M 0A9

  • Bausch Site Toronto General Hospital

    Toronto, Ontario, M5G 1N8

  • Bausch Site G.I.R.I. GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Bausch Site: Pharmaceutical Integrated Research Corporation

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Poland7 sites

  • Bausch Site 902

    Bydgoszcz, 85-605

  • Bausch Site 904

    Katowice, 40-752

  • Bausch Site 909

    Krakow, 30-721

  • Bausch Site 901

    Mysłowice, 41-400

  • Bausch Site 903

    Staszów, 28-200

  • Bausch Site 908

    Wroclaw, 50-220

  • Bausch Site 906

    Wroclaw, 51-162

Other trials in Poland

Spain7 sites

  • Bausch Site 931

    Barcelona, 08035

  • Bausch Site 937

    Madrid, 28034

  • Bausch Site 928

    Málaga, 29010

  • Bausch Site 936

    Pontevedra, 36164

  • Bausch Site 933

    Valencia, 46010

  • Bausch Site 935

    Valencia, 46014

  • Bausch Site 927

    Zaragoza, 50009

Other trials in Spain

Belgium6 sites

  • Bausch Site 972

    Antwerp, 2650

  • Bausch Site 978

    Genk, 3600

  • Bausch Site 973

    Ghent, 9000

  • Bausch Site 976

    Kortrijk, 8500

  • Bausch Site 974

    Liège, 4000

  • Bausch Site 975

    Mechelen, 2800

Other trials in Belgium

Bulgaria6 sites

  • Bausch Site 982

    Rousse, 7013

  • Bausch Site 969

    Sliven, 8800

  • Bausch Site 967

    Sofia, 1431

  • Bausch Site 968

    Sofia, 1606

  • Bausch Site 984

    Sofia, 1618

  • Bausch Site 966

    Stara Zagora, 6000

Other trials in Bulgaria

India6 sites

  • Bausch Site 352

    Belagavi, 590010

  • Bausch Site 350

    Mangaluru, 575003

  • Bausch Site 356

    Nagpur, 440010

  • Bausch Site 354

    Nashik, 422005

  • Bausch Site 361

    Secunderabad, 500003

  • Bausch Site 351

    Sūrat, 395009

Other trials in India

Italy5 sites

  • Bausch Site 881

    Milan, 20132

  • Bausch Site 883

    Naples, 80131

  • Bausch Site 884

    Novara, 28100

  • Bausch Site 882

    Palermo, 90127

  • Bausch Site 879

    Rozzano, 20089

Other trials in Italy

United Kingdom5 sites

  • Bausch Site 941

    Dundee, DD1 9SY

  • Bausch Site 947

    Hull, HU3 2JZ

  • Bausch Site 946

    Liverpool, L9 7AL

  • Bausch Site 945

    Nottingham, NG7 2UH

  • Bausch Site 942

    Plymouth, PL6 8DH

Other trials in United Kingdom

New Zealand3 sites

  • Bausch Site 779

    Christchurch, 8011

  • Bausch Site 776

    Grafton, 1023

  • Bausch Site 778

    Hamilton, 3240

Other trials in New Zealand

Australia2 sites

  • Bausch Site 709

    Camperdown, New South Wales, 2050

  • Bausch Site 710

    Westmead, New South Wales, 2145

Other trials in Australia

Hungary2 sites

  • Bausch Site 859

    Budapest, 1111

  • Bausch Site 856

    Debrecen, 4032

Other trials in Hungary

Puerto Rico2 sites

  • Bausch Site 440

    Guaynabo, 00966

  • Bausch Site 589

    San Juan, 00907

Other trials in Puerto Rico

Germany1 site

  • Bausch Site 737

    Berlin, 10117

Other trials in Germany

Mongolia1 site

  • Bausch Site 970

    Ulaanbaatar, 14230

Other trials in Mongolia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

Being tested
Rifaximin SSD, Placebo
Medical subject headings
Hepatic Encephalopathy

What participants receive

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

  • Rifaximin SSDDrug

    Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

  • PlaceboDrug

    Placebo Twice Daily

Study groups in NCT05297448
Study groupRoleWhat they receive
Rifaximin SSD-40mg IRExperimentalNot described
Receives: Drug: Rifaximin SSD
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.

    Measured: 72 weeks

Secondary outcomes (3)

  1. Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/clinic or death

    Measured: 72 weeks

  2. Time to all-cause hospitalization

    Measured: 72 weeks

  3. Time to first event of OHE that requires hospitalization, or all-cause death

    Measured: 72 weeks

Timeline

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

  1. First posted28 Mar 2022
  2. Study start3 Aug 2022
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
466 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297448
Sponsor's protocol ID
RNLC3132
Acronym
RED-C-3132
Status last verified
Sep 2025
First submitted
17 Mar 2022
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifaximin SSD in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 188 sites in 17 countries.

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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in United States, South Korea, France, Canada, Poland and 12 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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?

Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death. (time frame: 72 weeks). 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 NCT05297448.

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 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in