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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
517
Start Date
2022-08-03
Completion Date
2026-02-24
Last Updated
2026-10-28
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 Angelesq, 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