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

NCT05297448 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: RNLC3132
• Study Type: interventional
• Target: 466
• Locations: 17 countries
• Sites: 188

Brief 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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

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

  72 weeks

Secondary Outcomes (3)

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

  72 weeks

• Time to all-cause hospitalization

  72 weeks

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

  72 weeks

Study Arms (2)

Rifaximin SSD-40mg IR

EXPERIMENTAL

Drug: Rifaximin SSD

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rifaximin SSD DRUG

Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

Rifaximin SSD-40mg IR

Placebo DRUG

Placebo Twice Daily

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (188)

Bausch Site 591

Homewood, Alabama, 35209, United States

Location

Bausch Site 445

Chandler, Arizona, 85224, United States

Location

Bausch Site 453

Sun City, Arizona, 85351, United States

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Bausch Site 587

Tucson, Arizona, 85715, United States

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Bausch Site 550

Bakersfield, California, 93309, United States

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Bausch Site 415

Coronado, California, 92118, United States

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Bausch Site 585

Covina, California, 91722, United States

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Bausch Site 585

Covina, California, 91723, United States

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Bausch Site 592

Fresno, California, 93720, United States

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Bausch Site 582

Lancaster, California, 93534, United States

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Bausch Site 590

Long Beach, California, 90808, United States

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Bausch Site 414

Los Angeles, California, 90067, United States

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Bausch Site 405

Orange, California, 92868, United States

Location

Bausch Site 482

Valencia, California, 91355, United States

Location

Bausch Site 575

Colorado Springs, Colorado, 80907, United States

Location

Bausch Site 425

Doral, Florida, 33122, United States

Location

Bausch Site 449

Hialeah, Florida, 33012, United States

Location

Bausch Site 558

Hialeah, Florida, 33012, United States

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Bausch Site 418

Hialeah, Florida, 33013, United States

Location

Bausch Site 468

Hollywood, Florida, 33024, United States

Location

Bausch Site 495

Miami, Florida, 23229, United States

Location

Bausch Site 543

Miami, Florida, 33032, United States

Location

Bausch Site 479

Miami, Florida, 33125, United States

Location

Bausch Site 428

Miami, Florida, 33126, United States

Location

Bausch Site 470

Miami, Florida, 33134, United States

Location

Bausch Site 486

Miami, Florida, 33144, United States

Location

Bausch Site 552

Miami, Florida, 33165, United States

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Bausch Site 594

Miami, Florida, 33165, United States

Location

Bausch Site 456

Miami, Florida, 33175, United States

Location

Bausch Site 458

Miami, Florida, 33176, United States

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Bausch Site 435

Miami, Florida, 33186, United States

Location

Bausch Site 452

Miami Lakes, Florida, 33016, United States

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Bausch Site 431/443

Ocala, Florida, 34471, United States

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Bausch Site 450

Ocala, Florida, 34471, United States

Location

Bausch Site 446

Ocoee, Florida, 34761, United States

Location

Bausch Site 421

Orange City, Florida, 32763, United States

Location

Bausch Site 596

Orlando, Florida, 32808, United States

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Bausch Site 537

Palmetto Bay, Florida, 33157, United States

Location

Bausch Site 407

Port Orange, Florida, 32127, United States

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Bausch Site 454

Wellington, Florida, 33467, United States

Location

Bausch Site 429

Zephyrhills, Florida, 33542, United States

Location

Bausch Site 577

Macon, Georgia, 31201, United States

Location

Bausch Site 475

Gurnee, Illinois, 60031, United States

Location

Bausch Site 588

South Bend, Indiana, 46635, United States

Location

Bausch Site 466

West Des Moines, Iowa, 50266, United States

Location

Bausch Site 524

Topeka, Kansas, 66606, United States

Location

Bausch Site 457

Lafayette, Louisiana, 70503, United States

Location

Bausch Site 531

Marrero, Louisiana, 70072, United States

Location

Bausch Site 488

Metairie, Louisiana, 70006, United States

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Bausch Site 413

New Orleans, Louisiana, 70125, United States

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Bausch Site 442

Shreveport, Louisiana, 71105, United States

Location

Bausch Site 583

Greenbelt, Maryland, 20770, United States

Location

Bausch Site 463

Flowood, Mississippi, 39232, United States

Location

Bausch Site 460

Jefferson City, Missouri, 65109, United States

Location

Bausch Site 598

Florham Park, New Jersey, 07932, United States

Location

Bausch Site 597

Freehold, New Jersey, 07728, United States

Location

Bausch Site 411

Sparta, New Jersey, 07871, United States

Location

Bausch Site 455

Toms River, New Jersey, 08755, United States

Location

Bausch Site 436

East Syracuse, New York, 13057, United States

Location

Bausch Site 401

The Bronx, New York, 10467, United States

Location

Bausch Site 427

Asheville, North Carolina, 28801, United States

Location

Bausch Site 494

Monroe, North Carolina, 28112, United States

Location

Bausch Site 422

Smithfield, North Carolina, 27577, United States

Location

Bausch Site 410

Dayton, Ohio, 45414, United States

Location

Bausch Site 580

Liberty Township, Ohio, 45044, United States

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Bausch Site 403

Springboro, Ohio, 45066, United States

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Bausch Site 472

Westlake, Ohio, 44145, United States

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Bausch Site 581

Allentown, Pennsylvania, 18104, United States

Location

Bausch Site 400

Harrisburg, Pennsylvania, 17110, United States

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Bausch Site 576

Philadelphia, Pennsylvania, 19104, United States

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Bausch Site 484

Providence, Rhode Island, 02905, United States

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Bausch Site 599

Columbia, South Carolina, 29204, United States

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Bausch Site 480

Summerville, South Carolina, 29486, United States

Location

Bausch Site 423

Chattanooga, Tennessee, 37421, United States

Location

Bausch Site 434

Chattanooga, Tennessee, 37421, United States

Location

Bausch Site 579

Hermitage, Tennessee, 37076, United States

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Bausch Site 600

Union City, Tennessee, 38261, United States

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Bausch Site 406

Dallas, Texas, 75390, United States

Location

Bausch Site 519

Denison, Texas, 75929, United States

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Bausch Site 437

Houston, Texas, 77074, United States

Location

Bausch Site 447

Humble, Texas, 77346, United States

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Bausch Site 448

San Marcos, Texas, 78130, United States

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Bausch Site 409

Waco, Texas, 76712, United States

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Bausch Site 416

Wichita Falls, Texas, 76301, United States

Location

Bausch Site 402

Burlington, Vermont, 05401, United States

Location

Bausch Site 559

Norfolk, Virginia, 23502, United States

Location

Bausch Site 424

Richmond, Virginia, 23226, United States

Location

Bausch Site 490

Richmond, Virginia, 23229, United States

Location

Bausch Site 595

Richmond, Virginia, 23236, United States

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Bausch Site 404

Roanoke, Virginia, 24014, United States

Location

Bausch Site 709

Camperdown, New South Wales, 2050, Australia

Location

Bausch Site 710

Westmead, New South Wales, 2145, Australia

Location

Bausch Site 972

Antwerp, 2650, Belgium

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Bausch Site 978

Genk, 3600, Belgium

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Bausch Site 973

Ghent, 9000, Belgium

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Bausch Site 976

Kortrijk, 8500, Belgium

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Bausch Site 974

Liège, 4000, Belgium

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Bausch Site 975

Mechelen, 2800, Belgium

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Bausch Site 982

Rousse, 7013, Bulgaria

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Bausch Site 969

Sliven, 8800, Bulgaria

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Bausch Site 967

Sofia, 1431, Bulgaria

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Bausch Site 968

Sofia, 1606, Bulgaria

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Bausch Site 984

Sofia, 1618, Bulgaria

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Bausch Site 966

Stara Zagora, 6000, Bulgaria

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Bausch Site Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6, Canada

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Bausch Site University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

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

Vancouver, British Columbia, V6Z 2K5, Canada

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Bausch Site Barrie GI Associates

Barrie, Ontario, L4M 7G1, Canada

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Bausch Site Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

Bausch Site McMaster University Medical Centre - Hamilton Health Services

Hamilton, Ontario, L8V 1C3, Canada

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Bausch Site Albany Medical Clinic

Toronto, Ontario, M3M 0A9, Canada

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Bausch Site Toronto General Hospital

Toronto, Ontario, M5G 1N8, Canada

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Bausch Site: Pharmaceutical Integrated Research Corporation

Waterloo, Ontario, N2J 1C4, Canada

Location

Bausch Site Clinique Medicale L'Actuel

Montreal, Quebec, H2L 4P9, Canada

Location

Bausch Site: CHUM Centre de Recherche

Montreal, Quebec, HSX 0A9, Canada

Location

Bausch Site 605

Québec, G1V 4T3, Canada

Location

Bausch Site 804

Angers, 49100, France

Location

Bausch Site 818

Belfort, 90015, France

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Bausch Site 810

Besançon, 25000, France

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Bausch Site 802

Clermont-Ferrand, 63003, France

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Bausch Site 808

Limoges, 87042, France

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Bausch Site 805

Lyon, 69004, France

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Bausch Site 807

Nice, 06200, France

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Bausch Site 801

Paris, 75013, France

Location

Bausch Site 817

Paris, 75014, France

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Bausch Site 809

Pessac, 33604, France

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Bausch Site 815

Rennes, 35033, France

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Bausch Site 803

Toulouse, 31059, France

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Bausch Site 813

Vandœuvre-lès-Nancy, 54500, France

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Bausch Site 811

Villejuif, 94804, France

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Bausch Site 737

Berlin, 10117, Germany

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Bausch Site 859

Budapest, 1111, Hungary

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Bausch Site 856

Debrecen, 4032, Hungary

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Bausch Site 352

Belagavi, 590010, India

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Bausch Site 350

Mangaluru, 575003, India

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Bausch Site 356

Nagpur, 440010, India

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Bausch Site 354

Nashik, 422005, India

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Bausch Site 361

Secunderabad, 500003, India

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Bausch Site 351

Sūrat, 395009, India

Location

Bausch Site 881

Milan, 20132, Italy

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Bausch Site 883

Napoli, 80131, Italy

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Bausch Site 884

Novara, 28100, Italy

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Bausch Site 882

Palermo, 90127, Italy

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Bausch Site 879

Rozzano, 20089, Italy

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Bausch Site 970

Ulaanbaatar, 14230, Mongolia

Location

Bausch Site 779

Christchurch, 8011, New Zealand

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Bausch Site 776

Grafton, 1023, New Zealand

Location

Bausch Site 778

Hamilton, 3240, New Zealand

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Bausch Site 902

Bydgoszcz, 85-605, Poland

Location

Bausch Site 904

Katowice, 40-752, Poland

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Bausch Site 909

Krakow, 30-721, Poland

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Bausch Site 901

Mysłowice, 41-400, Poland

Location

Bausch Site 903

Staszów, 28-200, Poland

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Bausch Site 908

Wroclaw, 50-220, Poland

Location

Bausch Site 906

Wroclaw, 51-162, Poland

Location

Bausch Site 440

Guaynabo, 00966, Puerto Rico

Location

Bausch Site 589

San Juan, 00907, Puerto Rico

Location

Bausch Site 759

Busan, 47392, South Korea

Location

Bausch Site 751

Busan, 49241, South Korea

Location

Bausch Site 769

Daegu, 41944, South Korea

Location

Bausch Site 764

Daegu, 42601, South Korea

Location

Bausch Site 763

Daejeon, 34943, South Korea

Location

Bausch Site 768

Gangwon-do, 26426, South Korea

Location

Bausch Site 758

Goyang-si, 10408, South Korea

Location

Bausch Site 765

Gyeonggi-do, 15355, South Korea

Location

Bausch Site 754

Gyeongsang, 50612, South Korea

Location

Bausch Site 770

Seongnam-si, 13496, South Korea

Location

Bausch Site 757

Seoul, 013722, South Korea

Location

Bausch Site 766

Seoul, 01830, South Korea

Location

Bausch Site 752

Seoul, 03080, South Korea

Location

Bausch Site 762

Seoul, 03312, South Korea

Location

Bausch Site 760

Seoul, 06273, South Korea

Location

Bausch Site 753

Seoul, 06351, South Korea

Location

Bausch Site 767

Seoul, 06591, South Korea

Location

Bausch Site 755

Seoul, 08308, South Korea

Location

Bausch Site 761

Yongin-si, 16995, South Korea

Location

Bausch Site 931

Barcelona, 08035, Spain

Location

Bausch Site 937

Madrid, 28034, Spain

Location

Bausch Site 928

Málaga, 29010, Spain

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Bausch Site 936

Pontevedra, 36164, Spain

Location

Bausch Site 933

Valencia, 46010, Spain

Location

Bausch Site 935

Valencia, 46014, Spain

Location

Bausch Site 927

Zaragoza, 50009, Spain

Location

Bausch Site 941

Dundee, DD1 9SY, United Kingdom

Location

Bausch Site 947

Hull, HU3 2JZ, United Kingdom

Location

Bausch Site 946

Liverpool, L9 7AL, United Kingdom

Location

Bausch Site 945

Nottingham, NG7 2UH, United Kingdom

Location

Bausch Site 942

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Mader

  Bausch Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: August 3, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

PR (2); DE (1); IN (6); ES (7); AU (2); BU (6); PL (7); HU (2); BE (6); KR (19); MO (1); FR (14); IT (5); US (90); NZ (3); GB (5); CA (12)