Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis (RED-C-3132)

September 3, 2025 updated by: Bausch Health Americas, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Hepatic Encephalopathy

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Bausch Site 709
  - Westmead, New South Wales, Australia, 2145
    - Bausch Site 710
Belgium
- - Antwerp, Belgium, 2650
    - Bausch Site 972
  - Genk, Belgium, 3600
    - Bausch Site 978
  - Ghent, Belgium, 9000
    - Bausch Site 973
  - Kortrijk, Belgium, 8500
    - Bausch Site 976
  - Liège, Belgium, 4000
    - Bausch Site 974
  - Mechelen, Belgium, 2800
    - Bausch Site 975
Bulgaria
- - Rousse, Bulgaria, 7013
    - Bausch Site 982
  - Sliven, Bulgaria, 8800
    - Bausch Site 969
  - Sofia, Bulgaria, 1431
    - Bausch Site 967
  - Sofia, Bulgaria, 1606
    - Bausch Site 968
  - Sofia, Bulgaria, 1618
    - Bausch Site 984
  - Stara Zagora, Bulgaria, 6000
    - Bausch Site 966
Canada
- - Québec, Canada, G1V 4T3
    - Bausch Site 605
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Bausch Site Heritage Medical Research Clinic
  - Edmonton, Alberta, Canada, T6G 2B7
    - Bausch Site University of Alberta Hospital
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - Bausch Site G.I.R.I. GI Research Institute
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Bausch Site Barrie GI Associates
  - Brampton, Ontario, Canada, L6R 3J7
    - Bausch Site Brampton Civic Hospital
  - Hamilton, Ontario, Canada, L8V 1C3
    - Bausch Site McMaster University Medical Centre - Hamilton Health Services
  - Toronto, Ontario, Canada, M3M 0A9
    - Bausch Site Albany Medical Clinic
  - Toronto, Ontario, Canada, M5G 1N8
    - Bausch Site Toronto General Hospital
  - Waterloo, Ontario, Canada, N2J 1C4
    - Bausch Site: Pharmaceutical Integrated Research Corporation
- Quebec
  - Montreal, Quebec, Canada, H2L 4P9
    - Bausch Site Clinique Medicale L'Actuel
  - Montreal, Quebec, Canada, HSX 0A9
    - Bausch Site: CHUM Centre de Recherche
France
- - Angers, France, 49100
    - Bausch Site 804
  - Belfort, France, 90015
    - Bausch Site 818
  - Besançon, France, 25000
    - Bausch Site 810
  - Clermont-Ferrand, France, 63003
    - Bausch Site 802
  - Limoges, France, 87042
    - Bausch Site 808
  - Lyon, France, 69004
    - Bausch Site 805
  - Nice, France, 06200
    - Bausch Site 807
  - Paris, France, 75013
    - Bausch Site 801
  - Paris, France, 75014
    - Bausch Site 817
  - Pessac, France, 33604
    - Bausch Site 809
  - Rennes, France, 35033
    - Bausch Site 815
  - Toulouse, France, 31059
    - Bausch Site 803
  - Vandœuvre-lès-Nancy, France, 54500
    - Bausch Site 813
  - Villejuif, France, 94804
    - Bausch Site 811
Germany
- - Berlin, Germany, 10117
    - Bausch Site 737
Hungary
- - Budapest, Hungary, 1111
    - Bausch Site 859
  - Debrecen, Hungary, 4032
    - Bausch Site 856
India
- - Belagavi, India, 590010
    - Bausch Site 352
  - Mangaluru, India, 575003
    - Bausch Site 350
  - Nagpur, India, 440010
    - Bausch Site 356
  - Nashik, India, 422005
    - Bausch Site 354
  - Secunderabad, India, 500003
    - Bausch Site 361
  - Sūrat, India, 395009
    - Bausch Site 351
Italy
- - Milan, Italy, 20132
    - Bausch Site 881
  - Napoli, Italy, 80131
    - Bausch Site 883
  - Novara, Italy, 28100
    - Bausch Site 884
  - Palermo, Italy, 90127
    - Bausch Site 882
  - Rozzano, Italy, 20089
    - Bausch Site 879
Mongolia
- - Ulaanbaatar, Mongolia, 14230
    - Bausch Site 970
New Zealand
- - Christchurch, New Zealand, 8011
    - Bausch Site 779
  - Grafton, New Zealand, 1023
    - Bausch Site 776
  - Hamilton, New Zealand, 3240
    - Bausch Site 778
Poland
- - Bydgoszcz, Poland, 85-605
    - Bausch Site 902
  - Katowice, Poland, 40-752
    - Bausch Site 904
  - Krakow, Poland, 30-721
    - Bausch Site 909
  - Mysłowice, Poland, 41-400
    - Bausch Site 901
  - Staszów, Poland, 28-200
    - Bausch Site 903
  - Wroclaw, Poland, 50-220
    - Bausch Site 908
  - Wroclaw, Poland, 51-162
    - Bausch Site 906
Puerto Rico
- - Guaynabo, Puerto Rico, 00966
    - Bausch Site 440
  - San Juan, Puerto Rico, 00907
    - Bausch Site 589
South Korea
- - Busan, South Korea, 47392
    - Bausch Site 759
  - Busan, South Korea, 49241
    - Bausch Site 751
  - Daegu, South Korea, 41944
    - Bausch Site 769
  - Daegu, South Korea, 42601
    - Bausch Site 764
  - Daejeon, South Korea, 34943
    - Bausch Site 763
  - Gangwon-do, South Korea, 26426
    - Bausch Site 768
  - Goyang-si, South Korea, 10408
    - Bausch Site 758
  - Gyeonggi-do, South Korea, 15355
    - Bausch Site 765
  - Gyeongsang, South Korea, 50612
    - Bausch Site 754
  - Seongnam-si, South Korea, 13496
    - Bausch Site 770
  - Seoul, South Korea, 013722
    - Bausch Site 757
  - Seoul, South Korea, 01830
    - Bausch Site 766
  - Seoul, South Korea, 03080
    - Bausch Site 752
  - Seoul, South Korea, 03312
    - Bausch Site 762
  - Seoul, South Korea, 06273
    - Bausch Site 760
  - Seoul, South Korea, 06351
    - Bausch Site 753
  - Seoul, South Korea, 06591
    - Bausch Site 767
  - Seoul, South Korea, 08308
    - Bausch Site 755
  - Yongin-si, South Korea, 16995
    - Bausch Site 761
Spain
- - Barcelona, Spain, 08035
    - Bausch Site 931
  - Madrid, Spain, 28034
    - Bausch Site 937
  - Málaga, Spain, 29010
    - Bausch Site 928
  - Pontevedra, Spain, 36164
    - Bausch Site 936
  - Valencia, Spain, 46010
    - Bausch Site 933
  - Valencia, Spain, 46014
    - Bausch Site 935
  - Zaragoza, Spain, 50009
    - Bausch Site 927
United Kingdom
- - Dundee, United Kingdom, DD1 9SY
    - Bausch Site 941
  - Hull, United Kingdom, HU3 2JZ
    - Bausch Site 947
  - Liverpool, United Kingdom, L9 7AL
    - Bausch Site 946
  - Nottingham, United Kingdom, NG7 2UH
    - Bausch Site 945
  - Plymouth, United Kingdom, PL6 8DH
    - Bausch Site 942
United States
- Alabama
  - Homewood, Alabama, United States, 35209
    - Bausch Site 591
- Arizona
  - Chandler, Arizona, United States, 85224
    - Bausch Site 445
  - Sun City, Arizona, United States, 85351
    - Bausch Site 453
  - Tucson, Arizona, United States, 85715
    - Bausch Site 587
- California
  - Bakersfield, California, United States, 93309
    - Bausch Site 550
  - Coronado, California, United States, 92118
    - Bausch Site 415
  - Covina, California, United States, 91722
    - Bausch Site 585
  - Covina, California, United States, 91723
    - Bausch Site 585
  - Fresno, California, United States, 93720
    - Bausch Site 592
  - Lancaster, California, United States, 93534
    - Bausch Site 582
  - Long Beach, California, United States, 90808
    - Bausch Site 590
  - Los Angeles, California, United States, 90067
    - Bausch Site 414
  - Orange, California, United States, 92868
    - Bausch Site 405
  - Valencia, California, United States, 91355
    - Bausch Site 482
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Bausch Site 575
- Florida
  - Doral, Florida, United States, 33122
    - Bausch Site 425
  - Hialeah, Florida, United States, 33012
    - Bausch Site 449
  - Hialeah, Florida, United States, 33012
    - Bausch Site 558
  - Hialeah, Florida, United States, 33013
    - Bausch Site 418
  - Hollywood, Florida, United States, 33024
    - Bausch Site 468
  - Miami, Florida, United States, 23229
    - Bausch Site 495
  - Miami, Florida, United States, 33032
    - Bausch Site 543
  - Miami, Florida, United States, 33125
    - Bausch Site 479
  - Miami, Florida, United States, 33126
    - Bausch Site 428
  - Miami, Florida, United States, 33134
    - Bausch Site 470
  - Miami, Florida, United States, 33144
    - Bausch Site 486
  - Miami, Florida, United States, 33165
    - Bausch Site 552
  - Miami, Florida, United States, 33165
    - Bausch Site 594
  - Miami, Florida, United States, 33175
    - Bausch Site 456
  - Miami, Florida, United States, 33176
    - Bausch Site 458
  - Miami, Florida, United States, 33186
    - Bausch Site 435
  - Miami Lakes, Florida, United States, 33016
    - Bausch Site 452
  - Ocala, Florida, United States, 34471
    - Bausch Site 431/443
  - Ocala, Florida, United States, 34471
    - Bausch Site 450
  - Ocoee, Florida, United States, 34761
    - Bausch Site 446
  - Orange City, Florida, United States, 32763
    - Bausch Site 421
  - Orlando, Florida, United States, 32808
    - Bausch Site 596
  - Palmetto Bay, Florida, United States, 33157
    - Bausch Site 537
  - Port Orange, Florida, United States, 32127
    - Bausch Site 407
  - Wellington, Florida, United States, 33467
    - Bausch Site 454
  - Zephyrhills, Florida, United States, 33542
    - Bausch Site 429
- Georgia
  - Macon, Georgia, United States, 31201
    - Bausch Site 577
- Illinois
  - Gurnee, Illinois, United States, 60031
    - Bausch Site 475
- Indiana
  - South Bend, Indiana, United States, 46635
    - Bausch Site 588
- Iowa
  - West Des Moines, Iowa, United States, 50266
    - Bausch Site 466
- Kansas
  - Topeka, Kansas, United States, 66606
    - Bausch Site 524
- Louisiana
  - Lafayette, Louisiana, United States, 70503
    - Bausch Site 457
  - Marrero, Louisiana, United States, 70072
    - Bausch Site 531
  - Metairie, Louisiana, United States, 70006
    - Bausch Site 488
  - New Orleans, Louisiana, United States, 70125
    - Bausch Site 413
  - Shreveport, Louisiana, United States, 71105
    - Bausch Site 442
- Maryland
  - Greenbelt, Maryland, United States, 20770
    - Bausch Site 583
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Bausch Site 463
- Missouri
  - Jefferson City, Missouri, United States, 65109
    - Bausch Site 460
- New Jersey
  - Florham Park, New Jersey, United States, 07932
    - Bausch Site 598
  - Freehold, New Jersey, United States, 07728
    - Bausch Site 597
  - Sparta, New Jersey, United States, 07871
    - Bausch Site 411
  - Toms River, New Jersey, United States, 08755
    - Bausch Site 455
- New York
  - East Syracuse, New York, United States, 13057
    - Bausch Site 436
  - The Bronx, New York, United States, 10467
    - Bausch Site 401
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Bausch Site 427
  - Monroe, North Carolina, United States, 28112
    - Bausch Site 494
  - Smithfield, North Carolina, United States, 27577
    - Bausch Site 422
- Ohio
  - Dayton, Ohio, United States, 45414
    - Bausch Site 410
  - Liberty Township, Ohio, United States, 45044
    - Bausch Site 580
  - Springboro, Ohio, United States, 45066
    - Bausch Site 403
  - Westlake, Ohio, United States, 44145
    - Bausch Site 472
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18104
    - Bausch Site 581
  - Harrisburg, Pennsylvania, United States, 17110
    - Bausch Site 400
  - Philadelphia, Pennsylvania, United States, 19104
    - Bausch Site 576
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Bausch Site 484
- South Carolina
  - Columbia, South Carolina, United States, 29204
    - Bausch Site 599
  - Summerville, South Carolina, United States, 29486
    - Bausch Site 480
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Bausch Site 423
  - Chattanooga, Tennessee, United States, 37421
    - Bausch Site 434
  - Hermitage, Tennessee, United States, 37076
    - Bausch Site 579
  - Union City, Tennessee, United States, 38261
    - Bausch Site 600
- Texas
  - Dallas, Texas, United States, 75390
    - Bausch Site 406
  - Denison, Texas, United States, 75929
    - Bausch Site 519
  - Houston, Texas, United States, 77074
    - Bausch Site 437
  - Humble, Texas, United States, 77346
    - Bausch Site 447
  - San Marcos, Texas, United States, 78130
    - Bausch Site 448
  - Waco, Texas, United States, 76712
    - Bausch Site 409
  - Wichita Falls, Texas, United States, 76301
    - Bausch Site 416
- Vermont
  - Burlington, Vermont, United States, 05401
    - Bausch Site 402
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Bausch Site 559
  - Richmond, Virginia, United States, 23226
    - Bausch Site 424
  - Richmond, Virginia, United States, 23229
    - Bausch Site 490
  - Richmond, Virginia, United States, 23236
    - Bausch Site 595
  - Roanoke, Virginia, United States, 24014
    - Bausch Site 404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo Twice Daily
Experimental: Rifaximin SSD-40mg IR	Drug: Rifaximin SSD Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death. Time Frame: 72 weeks	72 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to all-cause hospitalization Time Frame: 72 weeks	72 weeks
Time to first event of OHE that requires hospitalization, or all-cause death Time Frame: 72 weeks	72 weeks
Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/clinic or death Time Frame: 72 weeks	72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

Study Director: Michael Mader, Bausch Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

RNLC3132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis (RED-C-3132)

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 Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Hepatic Encephalopathy

Clinical Trials on Rifaximin SSD

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