Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Phase 3

Active, not recruiting

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Placebo; Drug: Rifaximin SSD

• Registration Number: NCT05297448
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-08-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 466

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Rifaximin SSD-40mg IR	Rifaximin SSD	-

Primary Outcome Measures

Name	Time	Method
Time to first event of overt hepatic encephalopathy requiring hospitalization	72 weeks

Secondary Outcome Measures

Name	Time	Method
Time to first Conn score ≥ 2	72 weeks
Time to all-cause hospitalization	72 weeks
Time to first event of OHE that requires hospitalization, or all-cause death	72 weeks

Trial Locations

Locations (187)

Bausch Site 482; 🇺🇸 Valencia, California, United States

Bausch Site 452; 🇺🇸 Miami Lakes, Florida, United States

Bausch Site 577; 🇺🇸 Macon, Georgia, United States

Bausch Site 436; 🇺🇸 East Syracuse, New York, United States

Bausch Site 434; 🇺🇸 Chattanooga, Tennessee, United States

Bausch Site 495; 🇺🇸 Miami, Florida, United States

Bausch Site 594; 🇺🇸 Miami, Florida, United States

Bausch Site 435; 🇺🇸 Miami, Florida, United States

Bausch Site 973; 🇧🇪 Gent, Belgium

Bausch Site 975; 🇧🇪 Mechelen, Belgium

Bausch Site 591; 🇺🇸 Homewood, Alabama, United States

Bausch Site 592; 🇺🇸 Fresno, California, United States

Bausch Site 587; 🇺🇸 Tucson, Arizona, United States

Bausch Site 550; 🇺🇸 Bakersfield, California, United States

Bausch Site 453; 🇺🇸 Sun City, Arizona, United States

Bausch Site 414; 🇺🇸 Los Angeles, California, United States

Bausch Site 415; 🇺🇸 Coronado, California, United States

Bausch Site 590; 🇺🇸 Long Beach, California, United States

Bausch Site 585; 🇺🇸 Covina, California, United States

Bausch Site 425; 🇺🇸 Doral, Florida, United States

Bausch Site 449; 🇺🇸 Hialeah, Florida, United States

Bausch Site 531; 🇺🇸 Marrero, Louisiana, United States

Bausch Site 558; 🇺🇸 Hialeah, Florida, United States

Bausch Site 460; 🇺🇸 Jefferson City, Missouri, United States

Bausch Site 456; 🇺🇸 Miami, Florida, United States

Bausch Site 421; 🇺🇸 Orange City, Florida, United States

Bausch Site 454; 🇺🇸 Wellington, Florida, United States

Bausch Site 429; 🇺🇸 Zephyrhills, Florida, United States

Bausch Site 475; 🇺🇸 Gurnee, Illinois, United States

Bausch Site 403; 🇺🇸 Springboro, Ohio, United States

Bausch Site 418; 🇺🇸 Hialeah, Florida, United States

Bausch Site 446; 🇺🇸 Ocoee, Florida, United States

Bausch Site 486; 🇺🇸 Miami, Florida, United States

Bausch Site 427; 🇺🇸 Asheville, North Carolina, United States

Bausch Site 600; 🇺🇸 Union City, Tennessee, United States

Bausch Site 581; 🇺🇸 Allentown, Pennsylvania, United States

Bausch Site 458; 🇺🇸 Miami, Florida, United States

Bausch Site 455; 🇺🇸 Toms River, New Jersey, United States

Bausch Site 472; 🇺🇸 Westlake, Ohio, United States

Bausch Site 710; 🇦🇺 Westmead, New South Wales, Australia

Bausch Site 466; 🇺🇸 West Des Moines, Iowa, United States

Bausch Site 576; 🇺🇸 Philadelphia, Pennsylvania, United States

Bausch Site 524; 🇺🇸 Topeka, Kansas, United States

Bausch Site Brampton Civic Hospital; 🇨🇦 Brampton, Ontario, Canada

Bausch Site 488; 🇺🇸 Metairie, Louisiana, United States

Bausch Site 422; 🇺🇸 Smithfield, North Carolina, United States

Bausch Site 537; 🇺🇸 Palmetto Bay, Florida, United States

Bausch Site 583; 🇺🇸 Greenbelt, Maryland, United States

Bausch Site 968; 🇧🇬 Sofia, Bulgaria

Bausch Site 406; 🇺🇸 Dallas, Texas, United States

Bausch Site 519; 🇺🇸 Denison, Texas, United States

Bausch Site 437; 🇺🇸 Houston, Texas, United States

Bausch Site 463; 🇺🇸 Flowood, Mississippi, United States

Bausch Site 407; 🇺🇸 Port Orange, Florida, United States

Bausch Site 442; 🇺🇸 Shreveport, Louisiana, United States

Bausch Site 580; 🇺🇸 Liberty Township, Ohio, United States

Bausch Site 597; 🇺🇸 Freehold, New Jersey, United States

Bausch Site 480; 🇺🇸 Summerville, South Carolina, United States

Bausch Site 984; 🇧🇬 Sofia, Bulgaria

Bausch Site 976; 🇧🇪 Kortrijk, Belgium

Bausch Site 804; 🇫🇷 Angers, France

Bausch Site 982; 🇧🇬 Ruse, Bulgaria

Bausch Site 967; 🇧🇬 Sofia, Bulgaria

Bausch Site 966; 🇧🇬 Stara Zagora, Bulgaria

Bausch Site: Pharmaceutical Integrated Research Corporation; 🇨🇦 Waterloo, Ontario, Canada

Bausch Site: CHUM Centre de Recherche; 🇨🇦 Montreal, Quebec, Canada

Bausch Site 805; 🇫🇷 Lyon, France

Bausch Site 856; 🇭🇺 Debrecen, Hungary

Bausch Site 352; 🇮🇳 Belgaum, India

Bausch Site 765; 🇰🇷 Gyeonggi-do, Korea, Republic of

Bausch Site 764; 🇰🇷 Daegu, Korea, Republic of

Bausch Site 817; 🇫🇷 Paris, France

Bausch Site 807; 🇫🇷 Nice, France

Bausch Site 815; 🇫🇷 Rennes, France

Bausch Site 737; 🇩🇪 Berlin, Germany

Bausch Site 883; 🇮🇹 Napoli, Italy

Bausch Site 813; 🇫🇷 Vandœuvre-lès-Nancy, France

Bausch Site 811; 🇫🇷 Villejuif, France

Bausch Site 882; 🇮🇹 Palermo, Italy

Bausch Site 757; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 351; 🇮🇳 Sūrat, India

Bausch Site 770; 🇰🇷 Seongnam-si, Korea, Republic of

Bausch Site 906; 🇵🇱 Wrocław, Poland

Bausch Site 879; 🇮🇹 Rozzano, Italy

Bausch Site 440; 🇵🇷 Guaynabo, Puerto Rico

Bausch Site 769; 🇰🇷 Daegu, Korea, Republic of

Bausch Site 931; 🇪🇸 Barcelona, Spain

Bausch Site 759; 🇰🇷 Busan, Korea, Republic of

Bausch Site 935; 🇪🇸 Valencia, Spain

Bausch Site 589; 🇵🇷 San Juan, Puerto Rico

Bausch Site 947; 🇬🇧 Hull, United Kingdom

Bausch Site 766; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 936; 🇪🇸 Pontevedra, Spain

Bausch Site 767; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 927; 🇪🇸 Zaragoza, Spain

Bausch Site 937; 🇪🇸 Madrid, Spain

Bausch Site 928; 🇪🇸 Málaga, Spain

Bausch Site 933; 🇪🇸 Valencia, Spain

Bausch Site 881; 🇮🇹 Milano, Italy

Bausch Site 941; 🇬🇧 Dundee, United Kingdom

Bausch Site 942; 🇬🇧 Plymouth, United Kingdom

Bausch Site 801; 🇫🇷 Paris, France

Bausch Site 802; 🇫🇷 Clermont-Ferrand, France

Bausch Site 808; 🇫🇷 Limoges, France

Bausch Site 810; 🇫🇷 Besançon, France

Bausch Site McMaster University Medical Centre - Hamilton Health Services; 🇨🇦 Hamilton, Ontario, Canada

Bausch Site Clinique Medicale L'Actuel; 🇨🇦 Montreal, Quebec, Canada

Bausch Site 605; 🇨🇦 Quebec, Canada

Bausch Site 755; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 559; 🇺🇸 Norfolk, Virginia, United States

Bausch Site 468; 🇺🇸 Hollywood, Florida, United States

Bausch Site 484; 🇺🇸 Providence, Rhode Island, United States

Bausch Site 447; 🇺🇸 Humble, Texas, United States

Bausch Site 423; 🇺🇸 Chattanooga, Tennessee, United States

Bausch Site 416; 🇺🇸 Wichita Falls, Texas, United States

Bausch Site Heritage Medical Research Clinic; 🇨🇦 Calgary, Alberta, Canada

Bausch Site Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Bausch Site 803; 🇫🇷 Toulouse, France

Bausch Site 809; 🇫🇷 Pessac, France

Bausch Site 946; 🇬🇧 Liverpool, United Kingdom

Bausch Site 599; 🇺🇸 Columbia, South Carolina, United States

Bausch Site 768; 🇰🇷 Gangwon-do, Korea, Republic of

Bausch Site 445; 🇺🇸 Chandler, Arizona, United States

Bausch Site 582; 🇺🇸 Lancaster, California, United States

Bausch Site 405; 🇺🇸 Orange, California, United States

Bausch Site 575; 🇺🇸 Colorado Springs, Colorado, United States

Bausch Site 543; 🇺🇸 Miami, Florida, United States

Bausch Site 450; 🇺🇸 Ocala, 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 431/443; 🇺🇸 Ocala, Florida, United States

Bausch Site 552; 🇺🇸 Miami, Florida, United States

Bausch Site 588; 🇺🇸 South Bend, Indiana, United States

Bausch Site 457; 🇺🇸 Lafayette, Louisiana, United States

Bausch Site 411; 🇺🇸 Sparta, New Jersey, United States

Bausch Site 598; 🇺🇸 Florham Park, New Jersey, United States

Bausch Site 410; 🇺🇸 Dayton, Ohio, United States

Bausch Site 400; 🇺🇸 Harrisburg, Pennsylvania, United States

Bausch Site 579; 🇺🇸 Hermitage, Tennessee, United States

Bausch Site 409; 🇺🇸 Waco, Texas, United States

Bausch Site 974; 🇧🇪 Liege, Belgium

Bausch Site 978; 🇧🇪 Genk, Belgium

Bausch Site 404; 🇺🇸 Roanoke, Virginia, United States

Bausch Site 402; 🇺🇸 Burlington, Vermont, United States

Bausch Site 448; 🇺🇸 San Marcos, Texas, United States

Bausch Site 709; 🇦🇺 Camperdown, New South Wales, Australia

Bausch Site 969; 🇧🇬 Sliven, Bulgaria

Bausch Site G.I.R.I. GI Research Institute; 🇨🇦 Vancouver, British Columbia, Canada

Bausch Site Barrie GI Associates; 🇨🇦 Barrie, Ontario, Canada

Bausch Site Albany Medical Clinic; 🇨🇦 Toronto, Ontario, Canada

Bausch Site 818; 🇫🇷 Belfort, France

Bausch Site 884; 🇮🇹 Novara, Italy

Bausch Site 350; 🇮🇳 Mangaluru, India

Bausch Site 356; 🇮🇳 Nagpur, India

Bausch Site 754; 🇰🇷 Gyeongsang, Korea, Republic of

Bausch Site 751; 🇰🇷 Busan, Korea, Republic of

Bausch Site 758; 🇰🇷 Goyang-si, Korea, Republic of

Bausch Site 763; 🇰🇷 Daejeon, Korea, Republic of

Bausch Site 752; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 762; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 760; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 753; 🇰🇷 Seoul, Korea, Republic of

Bausch Site 776; 🇳🇿 Grafton, New Zealand

Bausch Site 761; 🇰🇷 Yongin-si, Korea, Republic of

Bausch Site 779; 🇳🇿 Christchurch, New Zealand

Bausch Site 904; 🇵🇱 Katowice, Poland

Bausch Site 778; 🇳🇿 Hamilton, New Zealand

Bausch Site 902; 🇵🇱 Bydgoszcz, Poland

Bausch Site 909; 🇵🇱 Kraków, Poland

Bausch Site 903; 🇵🇱 Staszów, Poland

Bausch Site 908; 🇵🇱 Wrocław, Poland

Bausch Site 945; 🇬🇧 Nottingham, United Kingdom

Bausch Site 901; 🇵🇱 Mysłowice, Poland

Bausch Site 970; 🇲🇳 Ulaan Baatar, Mongolia

Bausch Site 859; 🇭🇺 Budapest, Hungary

Bausch Site 354; 🇮🇳 Nashik, India

Bausch Site 361; 🇮🇳 Secunderabad, India

Bausch Site 972; 🇧🇪 Antwerpen, Belgium

Bausch Site 596; 🇺🇸 Orlando, Florida, United States

Bausch Site 413; 🇺🇸 New Orleans, Louisiana, 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 401; 🇺🇸 Bronx, New York, United States

Bausch Site University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Bausch Site 494; 🇺🇸 Monroe, North Carolina, United States