Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C-3131)

March 21, 2024 updated by: Bausch Health Americas, Inc.

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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

524

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Bausch Site 307
      • Kingswood, New South Wales, Australia, 2750
        • Bausch Site 300
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Bausch Site 306
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Bausch Site 304
      • Parkville, Victoria, Australia, 3050
        • Bausch Site 302
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Bausch Site 305
      • Perth, Western Australia, Australia, 6000
        • Bausch Site 303
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2R3
        • Bausch Site 202
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Bausch Site 203
      • Toronto, Ontario, Canada, M6H 3M1
        • Bausch Site 201
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Bausch Site 234
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Bausch Site 182
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Bausch Site 129
      • Peoria, Arizona, United States, 85381
        • Bausch Site 103
      • Phoenix, Arizona, United States, 85013
        • Bausch Site 180
      • Phoenix, Arizona, United States, 85054
        • Bausch Site 153
      • Tempe, Arizona, United States, 85283
        • Bausch Site 248
      • Tucson, Arizona, United States, 85712
        • Bausch Site 222
    • Arkansas
      • Little Rock, Arkansas, United States, 77205
        • Bausch Site 150
    • California
      • Bakersfield, California, United States, 93309
        • Bausch Site 164
      • Chula Vista, California, United States, 91910
        • Bausch Site 196
      • Chula Vista, California, United States, 91910
        • Bausch Site 226
      • Escondido, California, United States, 92025
        • Bausch Site 174
      • Fresno, California, United States, 93701
        • Bausch Site 163
      • Garden Grove, California, United States, 92844
        • Bausch Site 242
      • La Jolla, California, United States, 92037
        • Bausch Site 115
      • Lancaster, California, United States, 93534
        • Bausch Site 141
      • Los Angeles, California, United States, 90033
        • Bausch Site 140
      • Los Angeles, California, United States, 90095
        • Bausch Site 189
      • Orange, California, United States, 92868
        • Bausch Site 227
      • Pasadena, California, United States, 91105
        • Bausch Site 199
      • Redwood City, California, United States, 94063
        • Bausch Site 119
      • Rialto, California, United States, 92377
        • Bausch Site 102
      • San Diego, California, United States, 92114
        • Bausch Site 177
      • San Francisco, California, United States, 94109
        • Bausch Site 171
      • San Jose, California, United States, 95116
        • Bausch Site 214
      • Upland, California, United States, 91786
        • Bausch Site 183
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Bausch Site 143
      • Littleton, Colorado, United States, 80120
        • Bausch Site 212
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Bausch Site 151
    • Florida
      • Bradenton, Florida, United States, 34208
        • Bausch Site 220
      • Cape Coral, Florida, United States, 33914
        • Bausch Site 257
      • Cutler Bay, Florida, United States, 33157
        • Bausch Site 197
      • Fort Myers, Florida, United States, 33907
        • Bausch Site 249
      • Hialeah, Florida, United States, 33012
        • Bausch Site 173
      • Hialeah Gardens, Florida, United States, 33016
        • Bausch Site 238
      • Hollywood, Florida, United States, 33024
        • Bausch Site 235
      • Homestead, Florida, United States, 33032
        • Bausch Site 211
      • Inverness, Florida, United States, 34452
        • Bausch Site 139
      • Jacksonville, Florida, United States, 32256
        • Bausch Site 138
      • Lakewood Ranch, Florida, United States, 34211
        • Bausch Site 241
      • Miami, Florida, United States, 33032
        • Bausch Site 157
      • Miami, Florida, United States, 33126
        • Bausch Site 255
      • Miami, Florida, United States, 33144
        • Bausch Site 263
      • Miami, Florida, United States, 33144
        • Bausch Site 264
      • Miami, Florida, United States, 33145
        • Bausch Site 268
      • Miami, Florida, United States, 33155
        • Bausch Site 224
      • Miami, Florida, United States, 33156
        • Bausch Site 243
      • Miami, Florida, United States, 33165
        • Bausch Site 166
      • Miami, Florida, United States, 33173
        • Bausch Site 244
      • Miami, Florida, United States, 33174
        • Bausch Site 266
      • Miami, Florida, United States, 33176
        • Bausch Site 147
      • Miami, Florida, United States, 33176
        • Bausch Site 218
      • Miami, Florida, United States, 33176
        • Bausch Site 240
      • New Port Richey, Florida, United States, 34653
        • Bausch Site 186
      • Orlando, Florida, United States, 32803
        • Bausch Site 213
      • Pembroke Pines, Florida, United States, 33027
        • Bausch Site 267
      • Plantation, Florida, United States, 33317
        • Bausch Site 256
      • Venice, Florida, United States, 34285
        • Bausch Site 272
      • Weston, Florida, United States, 33331
        • Bausch Site 188
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Bausch Site 219
      • Augusta, Georgia, United States, 30904
        • Bausch Site 215
      • Dalton, Georgia, United States, 30720
        • Bausch Site 260
      • Marietta, Georgia, United States, 30060
        • Bausch Site 126
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Bausch Site 194
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Bausch Site 120
    • Iowa
      • Clive, Iowa, United States, 50325
        • Bausch Site 152
      • Iowa City, Iowa, United States, 52242
        • Bausch Site 135
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Bausch Site 128
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Bausch Site 124
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Bausch Site 237
      • Houma, Louisiana, United States, 70363
        • Bausch Site 261
      • Marrero, Louisiana, United States, 70072
        • Bausch Site 134
      • New Orleans, Louisiana, United States, 70112
        • Bausch Site 118
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Bausch Site 117
      • Glen Burnie, Maryland, United States, 21061
        • Bausch Site 230
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Bausch Site 132
      • Boston, Massachusetts, United States, 02114
        • Bausch Site 161
      • Boston, Massachusetts, United States, 02215
        • Bausch Site 223
      • Burlington, Massachusetts, United States, 01805
        • Bausch Site 146
      • New Bedford, Massachusetts, United States, 02740
        • Bausch Site 233
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Bausch Site 136
      • Detroit, Michigan, United States, 48201
        • Bausch Site 265
      • Detroit, Michigan, United States, 48202
        • Bausch Site 137
      • Wyoming, Michigan, United States, 49519
        • Bausch Site 149
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
        • Bausch Site 253
      • Minneapolis, Minnesota, United States, 55413
        • Bausch Site 271
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Bausch Site 148
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Bausch Site 178
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Bausch Site 251
      • Newark, New Jersey, United States, 07103
        • Bausch Site 191
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Bausch Site 216
    • New York
      • New York, New York, United States, 10021
        • Bausch Site 109
      • New York, New York, United States, 10029
        • Bausch Site 225
      • New York, New York, United States, 10032
        • Bausch Site 116
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Bausch Site 217
      • Durham, North Carolina, United States, 22710
        • Bausch Site 192
      • Statesville, North Carolina, United States, 28635
        • Bausch Site 269
      • Wilmington, North Carolina, United States, 28401
        • Bausch Site 245
      • Wilmington, North Carolina, United States, 28401
        • Bausch Site 273
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Bausch Site 114
      • Columbus, Ohio, United States, 43210
        • Bausch Site 154
      • Dayton, Ohio, United States, 45415
        • Bausch Site 167
      • Mentor, Ohio, United States, 44060
        • Bausch Site 185
    • Oklahoma
      • Moore, Oklahoma, United States, 73160
        • Bausch Site 270
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Bausch Site 110
      • Pittsburgh, Pennsylvania, United States, 15213
        • Bausch Site 228
      • Sayre, Pennsylvania, United States, 18840
        • Bausch Site 250
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Bausch Site 104
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Bausch Site 184
      • Nashville, Tennessee, United States, 37212
        • Bausch Site 181
    • Texas
      • Austin, Texas, United States, 78750
        • Bausch Site 221
      • Dallas, Texas, United States, 75024
        • Bausch Site 122
      • Dallas, Texas, United States, 75203
        • Bausch Site 144
      • Dallas, Texas, United States, 75216
        • Bausch Site 133
      • Dallas, Texas, United States, 75246
        • Bausch Site 107
      • Denison, Texas, United States, 75020
        • Bausch Site 123
      • El Paso, Texas, United States, 79936
        • Bausch Site 198
      • Fort Worth, Texas, United States, 76104
        • Bausch Site 172
      • Fort Worth, Texas, United States, 76104
        • Bausch Site 210
      • Harlingen, Texas, United States, 78550
        • Bausch Site 258
      • Houston, Texas, United States, 77024
        • Bausch Site 170
      • Houston, Texas, United States, 77030
        • Bausch Site 130
      • Houston, Texas, United States, 77030
        • Bausch Site 158
      • Houston, Texas, United States, 77030
        • Bausch Site 159
      • Houston, Texas, United States, 77094
        • Bausch Site 229
      • Houston, Texas, United States, 77099
        • Bausch Site 239
      • Mesquite, Texas, United States, 75149
        • Bausch Site 252
      • Pearland, Texas, United States, 77584
        • Bausch Site 195
      • Sugar Land, Texas, United States, 77479
        • Bausch Site 247
      • Sugar Land, Texas, United States, 77479
        • Bausch Site 262
      • Texas City, Texas, United States, 77591
        • Bausch Site 246
      • Waco, Texas, United States, 76710
        • Bausch Site 193
    • Utah
      • Murray, Utah, United States, 84121
        • Bausch Site 127
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Bausch Site 231
      • Norfolk, Virginia, United States, 23502
        • Bausch Site 175
      • Richmond, Virginia, United States, 23249
        • Bausch Site 113
      • Richmond, Virginia, United States, 23298
        • Bausch Site 111
    • Washington
      • Seattle, Washington, United States, 98195
        • Bausch Site 155
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Bausch Site 105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo Twice Daily
Experimental: Rifaximin SSD-40mg IR
Drug: Rifaximin SSD
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first event of overt hepatic encephalopathy requiring hospitalization
Time Frame: 72 weeks
72 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to all-cause hospitalization
Time Frame: 72 weeks
72 weeks
Time to first Conn score ≥ 2
Time Frame: 72 weeks
72 weeks
Time to first event of OHE that requires hospitalization, or all-cause death
Time Frame: 72 weeks
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

  • Study Director: Michael Mader, Bausch Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNLC3131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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