Clinical trial NCT05297448: Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hepatic Encephalopathy
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time to first event of overt hepatic encephalopathy requiring hospitalization
timeFrame: 72 weeks
Secondary outcomes:
measure: Time to first Conn score ≥ 2
timeFrame: 72 weeks
measure: Time to all-cause hospitalization
timeFrame: 72 weeks
measure: Time to first event of OHE that requires hospitalization, or all-cause death
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Bausch Site 591
state: Alabama
city: Chandler
country: United States
facility: Bausch Site 445
state: Arizona
city: Sun City
country: United States
facility: Bausch Site 453
state: Arizona
city: Tucson
country: United States
facility: Bausch Site 587
state: Arizona
city: Bakersfield
country: United States
facility: Bausch Site 550
state: California
city: Coronado
country: United States
facility: Bausch Site 415
state: California
city: Covina
country: United States
facility: Bausch Site 585
state: California
city: Covina
country: United States
facility: Bausch Site 585
state: California
city: Fresno
country: United States
facility: Bausch Site 592
state: California
city: Lancaster
country: United States
facility: Bausch Site 582
state: California
city: Long Beach
country: United States
facility: Bausch Site 590
state: California
city: Los Angeles
country: United States
facility: Bausch Site 414
state: California
city: Orange
country: United States
facility: Bausch Site 405
state: California
city: Valencia
country: United States
facility: Bausch Site 482
state: California
city: Colorado Springs
country: United States
facility: Bausch Site 575
state: Colorado
city: Doral
country: United States
facility: Bausch Site 425
state: Florida
city: Hialeah
country: United States
facility: Bausch Site 449
state: Florida
city: Hialeah
country: United States
facility: Bausch Site 558
state: Florida
city: Hialeah
country: United States
facility: Bausch Site 418
state: Florida
city: Hollywood
country: United States
facility: Bausch Site 468
state: Florida
city: Miami Lakes
country: United States
facility: Bausch Site 452
state: Florida
city: Miami
country: United States
facility: Bausch Site 495
state: Florida
city: Miami
country: United States
facility: Bausch Site 543
state: Florida
city: Miami
country: United States
facility: Bausch Site 479
state: Florida
city: Miami
country: United States
facility: Bausch Site 428
state: Florida
city: Miami
country: United States
facility: Bausch Site 470
state: Florida
city: Miami
country: United States
facility: Bausch Site 486
state: Florida
city: Miami
country: United States
facility: Bausch Site 552
state: Florida
city: Miami
country: United States
facility: Bausch Site 594
state: Florida
city: Miami
country: United States
facility: Bausch Site 456
state: Florida
city: Miami
country: United States
facility: Bausch Site 458
state: Florida
city: Miami
country: United States
facility: Bausch Site 435
state: Florida
city: Ocala
country: United States
facility: Bausch Site 431/443
state: Florida
city: Ocala
country: United States
facility: Bausch Site 450
state: Florida
city: Ocoee
country: United States
facility: Bausch Site 446
state: Florida
city: Orange City
country: United States
facility: Bausch Site 421
state: Florida
city: Orlando
country: United States
facility: Bausch Site 596
state: Florida
city: Palmetto Bay
country: United States
facility: Bausch Site 537
state: Florida
city: Port Orange
country: United States
facility: Bausch Site 407
state: Florida
city: Wellington
country: United States
facility: Bausch Site 454
state: Florida
city: Zephyrhills
country: United States
facility: Bausch Site 429
state: Florida
city: Macon
country: United States
facility: Bausch Site 577
state: Georgia
city: Gurnee
country: United States
facility: Bausch Site 475
state: Illinois
city: South Bend
country: United States
facility: Bausch Site 588
state: Indiana
city: West Des Moines
country: United States
facility: Bausch Site 466
state: Iowa
city: Topeka
country: United States
facility: Bausch Site 524
state: Kansas
city: Lafayette
country: United States
facility: Bausch Site 457
state: Louisiana
city: Marrero
country: United States
facility: Bausch Site 531
state: Louisiana
city: Metairie
country: United States
facility: Bausch Site 488
state: Louisiana
city: New Orleans
country: United States
facility: Bausch Site 413
state: Louisiana
city: Shreveport
country: United States
facility: Bausch Site 442
state: Louisiana
city: Greenbelt
country: United States
facility: Bausch Site 583
state: Maryland
city: Flowood
country: United States
facility: Bausch Site 463
state: Mississippi
city: Jefferson City
country: United States
facility: Bausch Site 460
state: Missouri
city: Florham Park
country: United States
facility: Bausch Site 598
state: New Jersey
city: Freehold
country: United States
facility: Bausch Site 597
state: New Jersey
city: Sparta
country: United States
facility: Bausch Site 411
state: New Jersey
city: Toms River
country: United States
facility: Bausch Site 455
state: New Jersey
city: Bronx
country: United States
facility: Bausch Site 401
state: New York
city: East Syracuse
country: United States
facility: Bausch Site 436
state: New York
city: Asheville
country: United States
facility: Bausch Site 427
state: North Carolina
city: Monroe
country: United States
facility: Bausch Site 494
state: North Carolina
city: Smithfield
country: United States
facility: Bausch Site 422
state: North Carolina
city: Dayton
country: United States
facility: Bausch Site 410
state: Ohio
city: Liberty Township
country: United States
facility: Bausch Site 580
state: Ohio
city: Springboro
country: United States
facility: Bausch Site 403
state: Ohio
city: Westlake
country: United States
facility: Bausch Site 472
state: Ohio
city: Allentown
country: United States
facility: Bausch Site 581
state: Pennsylvania
city: Harrisburg
country: United States
facility: Bausch Site 400
state: Pennsylvania
city: Philadelphia
country: United States
facility: Bausch Site 576
state: Pennsylvania
city: Providence
country: United States
facility: Bausch Site 484
state: Rhode Island
city: Columbia
country: United States
facility: Bausch Site 599
state: South Carolina
city: Summerville
country: United States
facility: Bausch Site 480
state: South Carolina
city: Chattanooga
country: United States
facility: Bausch Site 423
state: Tennessee
city: Chattanooga
country: United States
facility: Bausch Site 434
state: Tennessee
city: Hermitage
country: United States
facility: Bausch Site 579
state: Tennessee
city: Union City
country: United States
facility: Bausch Site 600
state: Tennessee
city: Dallas
country: United States
facility: Bausch Site 406
state: Texas
city: Denison
country: United States
facility: Bausch Site 519
state: Texas
city: Houston
country: United States
facility: Bausch Site 437
state: Texas
city: Humble
country: United States
facility: Bausch Site 447
state: Texas
city: San Marcos
country: United States
facility: Bausch Site 448
state: Texas
city: Waco
country: United States
facility: Bausch Site 409
state: Texas
city: Wichita Falls
country: United States
facility: Bausch Site 416
state: Texas
city: Burlington
country: United States
facility: Bausch Site 402
state: Vermont
city: Norfolk
country: United States
facility: Bausch Site 559
state: Virginia
city: Richmond
country: United States
facility: Bausch Site 424
state: Virginia
city: Richmond
country: United States
facility: Bausch Site 490
state: Virginia
city: Richmond
country: United States
facility: Bausch Site 595
state: Virginia
city: Roanoke
country: United States
facility: Bausch Site 404
state: Virginia
city: Camperdown
country: Australia
facility: Bausch Site 709
state: New South Wales
city: Westmead
country: Australia
facility: Bausch Site 710
state: New South Wales
city: Antwerpen
country: Belgium
facility: Bausch Site 972
city: Genk
country: Belgium
facility: Bausch Site 978
city: Gent
country: Belgium
facility: Bausch Site 973
city: Kortrijk
country: Belgium
facility: Bausch Site 976
city: Liege
country: Belgium
facility: Bausch Site 974
city: Mechelen
country: Belgium
facility: Bausch Site 975
city: Ruse
country: Bulgaria
facility: Bausch Site 982
city: Sliven
country: Bulgaria
facility: Bausch Site 969
city: Sofia
country: Bulgaria
facility: Bausch Site 967
city: Sofia
country: Bulgaria
facility: Bausch Site 968
city: Sofia
country: Bulgaria
facility: Bausch Site 984
city: Stara Zagora
country: Bulgaria
facility: Bausch Site 966
city: Calgary
country: Canada
facility: Bausch Site Heritage Medical Research Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Bausch Site University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Bausch Site G.I.R.I. GI Research Institute
state: British Columbia
city: Barrie
country: Canada
facility: Bausch Site Barrie GI Associates
state: Ontario
city: Brampton
country: Canada
facility: Bausch Site Brampton Civic Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Bausch Site McMaster University Medical Centre - Hamilton Health Services
state: Ontario
city: Toronto
country: Canada
facility: Bausch Site Albany Medical Clinic
state: Ontario
city: Toronto
country: Canada
facility: Bausch Site Toronto General Hospital
state: Ontario
city: Waterloo
country: Canada
facility: Bausch Site: Pharmaceutical Integrated Research Corporation
state: Ontario
city: Montreal
country: Canada
facility: Bausch Site Clinique Medicale L'Actuel
state: Quebec
city: Montreal
country: Canada
facility: Bausch Site: CHUM Centre de Recherche
state: Quebec
city: Quebec
country: Canada
facility: Bausch Site 605
city: Angers
country: France
facility: Bausch Site 804
city: Belfort
country: France
facility: Bausch Site 818
city: Besançon
country: France
facility: Bausch Site 810
city: Clermont-Ferrand
country: France
facility: Bausch Site 802
city: Limoges
country: France
facility: Bausch Site 808
city: Lyon
country: France
facility: Bausch Site 805
city: Nice
country: France
facility: Bausch Site 807
city: Paris
country: France
facility: Bausch Site 801
city: Paris
country: France
facility: Bausch Site 817
city: Pessac
country: France
facility: Bausch Site 809
city: Rennes
country: France
facility: Bausch Site 815
city: Toulouse
country: France
facility: Bausch Site 803
city: Vandœuvre-lès-Nancy
country: France
facility: Bausch Site 813
city: Villejuif
country: France
facility: Bausch Site 811
city: Berlin
country: Germany
facility: Bausch Site 737
city: Budapest
country: Hungary
facility: Bausch Site 859
city: Debrecen
country: Hungary
facility: Bausch Site 856
city: Belgaum
country: India
facility: Bausch Site 352
city: Mangaluru
country: India
facility: Bausch Site 350
city: Nagpur
country: India
facility: Bausch Site 356
city: Nashik
country: India
facility: Bausch Site 354
city: Secunderabad
country: India
facility: Bausch Site 361
city: Sūrat
country: India
facility: Bausch Site 351
city: Milano
country: Italy
facility: Bausch Site 881
city: Napoli
country: Italy
facility: Bausch Site 883
city: Novara
country: Italy
facility: Bausch Site 884
city: Palermo
country: Italy
facility: Bausch Site 882
city: Rozzano
country: Italy
facility: Bausch Site 879
city: Busan
country: Korea, Republic of
facility: Bausch Site 759
city: Busan
country: Korea, Republic of
facility: Bausch Site 751
city: Daegu
country: Korea, Republic of
facility: Bausch Site 769
city: Daegu
country: Korea, Republic of
facility: Bausch Site 764
city: Daejeon
country: Korea, Republic of
facility: Bausch Site 763
city: Gangwon-do
country: Korea, Republic of
facility: Bausch Site 768
city: Goyang-si
country: Korea, Republic of
facility: Bausch Site 758
city: Gyeonggi-do
country: Korea, Republic of
facility: Bausch Site 765
city: Gyeongsang
country: Korea, Republic of
facility: Bausch Site 754
city: Seongnam-si
country: Korea, Republic of
facility: Bausch Site 770
city: Seoul
country: Korea, Republic of
facility: Bausch Site 757
city: Seoul
country: Korea, Republic of
facility: Bausch Site 766
city: Seoul
country: Korea, Republic of
facility: Bausch Site 752
city: Seoul
country: Korea, Republic of
facility: Bausch Site 762
city: Seoul
country: Korea, Republic of
facility: Bausch Site 760
city: Seoul
country: Korea, Republic of
facility: Bausch Site 753
city: Seoul
country: Korea, Republic of
facility: Bausch Site 767
city: Seoul
country: Korea, Republic of
facility: Bausch Site 755
city: Yongin-si
country: Korea, Republic of
facility: Bausch Site 761
city: Ulaan Baatar
country: Mongolia
facility: Bausch Site 970
city: Christchurch
country: New Zealand
facility: Bausch Site 779
city: Grafton
country: New Zealand
facility: Bausch Site 776
city: Hamilton
country: New Zealand
facility: Bausch Site 778
city: Bydgoszcz
country: Poland
facility: Bausch Site 902
city: Katowice
country: Poland
facility: Bausch Site 904
city: Kraków
country: Poland
facility: Bausch Site 909
city: Mysłowice
country: Poland
facility: Bausch Site 901
city: Staszów
country: Poland
facility: Bausch Site 903
city: Wrocław
country: Poland
facility: Bausch Site 908
city: Wrocław
country: Poland
facility: Bausch Site 906
city: Guaynabo
country: Puerto Rico
facility: Bausch Site 440
city: San Juan
country: Puerto Rico
facility: Bausch Site 589
city: Barcelona
country: Spain
facility: Bausch Site 931
city: Madrid
country: Spain
facility: Bausch Site 937
city: Málaga
country: Spain
facility: Bausch Site 928
city: Pontevedra
country: Spain
facility: Bausch Site 936
city: Valencia
country: Spain
facility: Bausch Site 933
city: Valencia
country: Spain
facility: Bausch Site 935
city: Zaragoza
country: Spain
facility: Bausch Site 927
city: Dundee
country: United Kingdom
facility: Bausch Site 941
city: Hull
country: United Kingdom
facility: Bausch Site 947
city: Liverpool
country: United Kingdom
facility: Bausch Site 946
city: Nottingham
country: United Kingdom
facility: Bausch Site 945
city: Plymouth
country: United Kingdom
facility: Bausch Site 942
Study officials:
affiliation: Bausch Health
name: Michael Mader
role: STUDY_DIRECTOR
References: