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Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
Sponsor: Bausch Health Americas, Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
466
Start Date
2022-08-03
Completion Date
2026-01
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
Rifaximin SSD
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
Placebo
Placebo Twice Daily
Locations (188)
Bausch Site 591
Homewood, Alabama, United States
Bausch Site 445
Chandler, Arizona, United States
Bausch Site 453
Sun City, Arizona, United States
Bausch Site 587
Tucson, Arizona, United States
Bausch Site 550
Bakersfield, California, United States
Bausch Site 415
Coronado, California, United States
Bausch Site 585
Covina, California, United States
Bausch Site 585
Covina, California, United States
Bausch Site 592
Fresno, California, United States
Bausch Site 582
Lancaster, California, United States
Bausch Site 590
Long Beach, California, United States
Bausch Site 414
Los Angeles, California, United States
Bausch Site 405
Orange, California, United States
Bausch Site 482
Valencia, California, United States
Bausch Site 575
Colorado Springs, Colorado, United States
Bausch Site 425
Doral, Florida, United States
Bausch Site 449
Hialeah, Florida, United States
Bausch Site 558
Hialeah, Florida, United States
Bausch Site 418
Hialeah, Florida, United States
Bausch Site 468
Hollywood, Florida, United States
Bausch Site 495
Miami, Florida, United States
Bausch Site 543
Miami, Florida, United States
Bausch Site 479
Miami, Florida, United States
Bausch Site 428
Miami, Florida, United States
Bausch Site 470
Miami, Florida, United States
Bausch Site 486
Miami, Florida, United States
Bausch Site 552
Miami, Florida, United States
Bausch Site 594
Miami, Florida, United States
Bausch Site 456
Miami, Florida, United States
Bausch Site 458
Miami, Florida, United States
Bausch Site 435
Miami, Florida, United States
Bausch Site 452
Miami Lakes, Florida, United States
Bausch Site 431/443
Ocala, Florida, United States
Bausch Site 450
Ocala, Florida, United States
Bausch Site 446
Ocoee, Florida, United States
Bausch Site 421
Orange City, Florida, United States
Bausch Site 596
Orlando, Florida, United States
Bausch Site 537
Palmetto Bay, Florida, United States
Bausch Site 407
Port Orange, Florida, United States
Bausch Site 454
Wellington, Florida, United States
Bausch Site 429
Zephyrhills, Florida, United States
Bausch Site 577
Macon, Georgia, United States
Bausch Site 475
Gurnee, Illinois, United States
Bausch Site 588
South Bend, Indiana, United States
Bausch Site 466
West Des Moines, Iowa, United States
Bausch Site 524
Topeka, Kansas, United States
Bausch Site 457
Lafayette, Louisiana, United States
Bausch Site 531
Marrero, Louisiana, United States
Bausch Site 488
Metairie, Louisiana, United States
Bausch Site 413
New Orleans, Louisiana, United States
Bausch Site 442
Shreveport, Louisiana, United States
Bausch Site 583
Greenbelt, Maryland, United States
Bausch Site 463
Flowood, Mississippi, United States
Bausch Site 460
Jefferson City, Missouri, United States
Bausch Site 598
Florham Park, New Jersey, United States
Bausch Site 597
Freehold, New Jersey, United States
Bausch Site 411
Sparta, New Jersey, United States
Bausch Site 455
Toms River, New Jersey, United States
Bausch Site 436
East Syracuse, New York, United States
Bausch Site 401
The Bronx, New York, United States
Bausch Site 427
Asheville, North Carolina, United States
Bausch Site 494
Monroe, North Carolina, United States
Bausch Site 422
Smithfield, North Carolina, United States
Bausch Site 410
Dayton, Ohio, United States
Bausch Site 580
Liberty Township, Ohio, United States
Bausch Site 403
Springboro, Ohio, United States
Bausch Site 472
Westlake, Ohio, United States
Bausch Site 581
Allentown, Pennsylvania, United States
Bausch Site 400
Harrisburg, Pennsylvania, United States
Bausch Site 576
Philadelphia, Pennsylvania, United States
Bausch Site 484
Providence, Rhode Island, United States
Bausch Site 599
Columbia, South Carolina, United States
Bausch Site 480
Summerville, South Carolina, United States
Bausch Site 423
Chattanooga, Tennessee, United States
Bausch Site 434
Chattanooga, Tennessee, United States
Bausch Site 579
Hermitage, Tennessee, United States
Bausch Site 600
Union City, Tennessee, United States
Bausch Site 406
Dallas, Texas, United States
Bausch Site 519
Denison, Texas, United States
Bausch Site 437
Houston, Texas, United States
Bausch Site 447
Humble, Texas, United States
Bausch Site 448
San Marcos, Texas, United States
Bausch Site 409
Waco, Texas, United States
Bausch Site 416
Wichita Falls, Texas, United States
Bausch Site 402
Burlington, Vermont, United States
Bausch Site 559
Norfolk, Virginia, United States
Bausch Site 424
Richmond, Virginia, United States
Bausch Site 490
Richmond, Virginia, United States
Bausch Site 595
Richmond, Virginia, United States
Bausch Site 404
Roanoke, Virginia, United States
Bausch Site 709
Camperdown, New South Wales, Australia
Bausch Site 710
Westmead, New South Wales, Australia
Bausch Site 972
Antwerp, Belgium
Bausch Site 978
Genk, Belgium
Bausch Site 973
Ghent, Belgium
Bausch Site 976
Kortrijk, Belgium
Bausch Site 974
Liège, Belgium
Bausch Site 975
Mechelen, Belgium
Bausch Site 982
Rousse, Bulgaria
Bausch Site 969
Sliven, Bulgaria
Bausch Site 967
Sofia, Bulgaria
Bausch Site 968
Sofia, Bulgaria
Bausch Site 984
Sofia, Bulgaria
Bausch Site 966
Stara Zagora, Bulgaria
Bausch Site Heritage Medical Research Clinic
Calgary, Alberta, Canada
Bausch Site University of Alberta Hospital
Edmonton, Alberta, Canada
Bausch Site G.I.R.I. GI Research Institute
Vancouver, British Columbia, Canada
Bausch Site Barrie GI Associates
Barrie, Ontario, Canada
Bausch Site Brampton Civic Hospital
Brampton, Ontario, Canada
Bausch Site McMaster University Medical Centre - Hamilton Health Services
Hamilton, Ontario, Canada
Bausch Site Albany Medical Clinic
Toronto, Ontario, Canada
Bausch Site Toronto General Hospital
Toronto, Ontario, Canada
Bausch Site: Pharmaceutical Integrated Research Corporation
Waterloo, Ontario, Canada
Bausch Site Clinique Medicale L'Actuel
Montreal, Quebec, Canada
Bausch Site: CHUM Centre de Recherche
Montreal, Quebec, Canada
Bausch Site 605
Québec, Canada
Bausch Site 804
Angers, France
Bausch Site 818
Belfort, France
Bausch Site 810
Besançon, France
Bausch Site 802
Clermont-Ferrand, France
Bausch Site 808
Limoges, France
Bausch Site 805
Lyon, France
Bausch Site 807
Nice, France
Bausch Site 801
Paris, France
Bausch Site 817
Paris, France
Bausch Site 809
Pessac, France
Bausch Site 815
Rennes, France
Bausch Site 803
Toulouse, France
Bausch Site 813
Vandœuvre-lès-Nancy, France
Bausch Site 811
Villejuif, France
Bausch Site 737
Berlin, Germany
Bausch Site 859
Budapest, Hungary
Bausch Site 856
Debrecen, Hungary
Bausch Site 352
Belagavi, India
Bausch Site 350
Mangaluru, India
Bausch Site 356
Nagpur, India
Bausch Site 354
Nashik, India
Bausch Site 361
Secunderabad, India
Bausch Site 351
Sūrat, India
Bausch Site 881
Milan, Italy
Bausch Site 883
Naples, Italy
Bausch Site 884
Novara, Italy
Bausch Site 882
Palermo, Italy
Bausch Site 879
Rozzano, Italy
Bausch Site 970
Ulaanbaatar, Mongolia
Bausch Site 779
Christchurch, New Zealand
Bausch Site 776
Grafton, New Zealand
Bausch Site 778
Hamilton, New Zealand
Bausch Site 902
Bydgoszcz, Poland
Bausch Site 904
Katowice, Poland
Bausch Site 909
Krakow, Poland
Bausch Site 901
Mysłowice, Poland
Bausch Site 903
Staszów, Poland
Bausch Site 908
Wroclaw, Poland
Bausch Site 906
Wroclaw, Poland
Bausch Site 440
Guaynabo, Puerto Rico
Bausch Site 589
San Juan, Puerto Rico
Bausch Site 759
Busan, South Korea
Bausch Site 751
Busan, South Korea
Bausch Site 769
Daegu, South Korea
Bausch Site 764
Daegu, South Korea
Bausch Site 763
Daejeon, South Korea
Bausch Site 768
Gangwon-do, South Korea
Bausch Site 758
Goyang-si, South Korea
Bausch Site 765
Gyeonggi-do, South Korea
Bausch Site 754
Gyeongsang, South Korea
Bausch Site 770
Seongnam-si, South Korea
Bausch Site 757
Seoul, South Korea
Bausch Site 766
Seoul, South Korea
Bausch Site 752
Seoul, South Korea
Bausch Site 762
Seoul, South Korea
Bausch Site 760
Seoul, South Korea
Bausch Site 753
Seoul, South Korea
Bausch Site 767
Seoul, South Korea
Bausch Site 755
Seoul, South Korea
Bausch Site 761
Yongin-si, South Korea
Bausch Site 931
Barcelona, Spain
Bausch Site 937
Madrid, Spain
Bausch Site 928
Málaga, Spain
Bausch Site 936
Pontevedra, Spain
Bausch Site 933
Valencia, Spain
Bausch Site 935
Valencia, Spain
Bausch Site 927
Zaragoza, Spain
Bausch Site 941
Dundee, United Kingdom
Bausch Site 947
Hull, United Kingdom
Bausch Site 946
Liverpool, United Kingdom
Bausch Site 945
Nottingham, United Kingdom
Bausch Site 942
Plymouth, United Kingdom