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

Last updated: March 21, 2024
Sponsor: Bausch Health Americas, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hepatic Encephalopathy

Arginase Deficiency

Liver Disorders

Treatment

Rifaximin SSD

Placebo

Clinical Study ID

NCT05071716
RNLC3131
  • Ages 18-85
  • All Genders

Study Summary

Study RNLC3131 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

Inclusion

Key Inclusion Criteria:

  • Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) notrequiring 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.

Exclusion

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

Total Participants: 524
Treatment Group(s): 2
Primary Treatment: Rifaximin SSD
Phase: 3
Study Start date:
April 07, 2022
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Bausch Site 307

    Concord, New South Wales 2139
    Australia

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    Darlinghurst, New South Wales 2010
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    Kingswood, New South Wales 2750
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    Bedford Park, South Australia 5042
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    Box Hill, Victoria 3128
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    Parkville, Victoria 3050
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    Murdoch, Western Australia 6150
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    Perth, Western Australia 6000
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    Edmonton, Alberta T6G2R3
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    Toronto, Ontario M6H 3M1
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    Toronto, Ontario M5G 2C4
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    San Juan, 00927
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    Dothan, Alabama 36301
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    Chandler, Arizona 85224
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    Peoria, Arizona 85381
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    Phoenix, Arizona 85054
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    Phoenix, Arizona 85013
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    Tempe, Arizona 85283
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    Tucson, Arizona 85712
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    Little Rock, Arkansas 77205
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    Bakersfield, California 93309
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    Chula Vista, California 91910
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    Detroit, Michigan 48201
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    Wyoming, Michigan 49519
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    Minneapolis, Minnesota 55413
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    Jackson, Mississippi 39216
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    Albuquerque, New Mexico 87109
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    Nashville, Tennessee 37212
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    Austin, Texas 76710
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    Milwaukee, Wisconsin 53226
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