Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
NCT ID: NCT05071716
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
524 participants
INTERVENTIONAL
2022-04-07
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Rifaximin SSD-40mg IR
Rifaximin SSD
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
Placebo
Placebo
Placebo Twice Daily
Interventions
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Rifaximin SSD
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
Placebo
Placebo Twice Daily
Eligibility Criteria
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Inclusion Criteria
* Conn (West Haven Criteria) score of \< 2.
* Mini-Mental State Examination (MMSE) score \> 24 at screening.
* ≥ 18 and ≤ 85 years of age.
Exclusion Criteria
* History of SBP
* History of EVB or AKI-HRS within 6 months
* History of OHE episode (Conn score ≥ 2)
18 Years
85 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Mader
Role: STUDY_DIRECTOR
Bausch Health
Locations
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Bausch Site 182
Dothan, Alabama, United States
Bausch Site 129
Chandler, Arizona, United States
Bausch Site 103
Peoria, Arizona, United States
Bausch Site 180
Phoenix, Arizona, United States
Bausch Site 153
Phoenix, Arizona, United States
Bausch Site 248
Tempe, Arizona, United States
Bausch Site 222
Tucson, Arizona, United States
Bausch Site 150
Little Rock, Arkansas, United States
Bausch Site 164
Bakersfield, California, United States
Bausch Site 196
Chula Vista, California, United States
Bausch Site 226
Chula Vista, California, United States
Bausch Site 174
Escondido, California, United States
Bausch Site 163
Fresno, California, United States
Bausch Site 242
Garden Grove, California, United States
Bausch Site 115
La Jolla, California, United States
Bausch Site 141
Lancaster, California, United States
Bausch Site 140
Los Angeles, California, United States
Bausch Site 189
Los Angeles, California, United States
Bausch Site 227
Orange, California, United States
Bausch Site 199
Pasadena, California, United States
Bausch Site 119
Redwood City, California, United States
Bausch Site 102
Rialto, California, United States
Bausch Site 177
San Diego, California, United States
Bausch Site 171
San Francisco, California, United States
Bausch Site 214
San Jose, California, United States
Bausch Site 183
Upland, California, United States
Bausch Site 143
Englewood, Colorado, United States
Bausch Site 212
Littleton, Colorado, United States
Bausch Site 151
Bristol, Connecticut, United States
Bausch Site 220
Bradenton, Florida, United States
Bausch Site 257
Cape Coral, Florida, United States
Bausch Site 197
Cutler Bay, Florida, United States
Bausch Site 249
Fort Myers, Florida, United States
Bausch Site 173
Hialeah, Florida, United States
Bausch Site 238
Hialeah Gardens, Florida, United States
Bausch Site 235
Hollywood, Florida, United States
Bausch Site 211
Homestead, Florida, United States
Bausch Site 139
Inverness, Florida, United States
Bausch Site 138
Jacksonville, Florida, United States
Bausch Site 241
Lakewood Rch, Florida, United States
Bausch Site 157
Miami, Florida, United States
Bausch Site 255
Miami, Florida, United States
Bausch Site 263
Miami, Florida, United States
Bausch Site 264
Miami, Florida, United States
Bausch Site 268
Miami, Florida, United States
Bausch Site 224
Miami, Florida, United States
Bausch Site 243
Miami, Florida, United States
Bausch Site 166
Miami, Florida, United States
Bausch Site 244
Miami, Florida, United States
Bausch Site 266
Miami, Florida, United States
Bausch Site 147
Miami, Florida, United States
Bausch Site 218
Miami, Florida, United States
Bausch Site 240
Miami, Florida, United States
Bausch Site 186
New Port Richey, Florida, United States
Bausch Site 213
Orlando, Florida, United States
Bausch Site 267
Pembroke Pines, Florida, United States
Bausch Site 256
Plantation, Florida, United States
Bausch Site 272
Venice, Florida, United States
Bausch Site 188
Weston, Florida, United States
Bausch Site 219
Atlanta, Georgia, United States
Bausch Site 215
Augusta, Georgia, United States
Bausch Site 260
Dalton, Georgia, United States
Bausch Site 126
Marietta, Georgia, United States
Bausch Site 194
Chicago, Illinois, United States
Bausch Site 120
Indianapolis, Indiana, United States
Bausch Site 152
Clive, Iowa, United States
Bausch Site 135
Iowa City, Iowa, United States
Bausch Site 128
Topeka, Kansas, United States
Bausch Site 124
Louisville, Kentucky, United States
Bausch Site 237
Baton Rouge, Louisiana, United States
Bausch Site 261
Houma, Louisiana, United States
Bausch Site 134
Marrero, Louisiana, United States
Bausch Site 118
New Orleans, Louisiana, United States
Bausch Site 117
Baltimore, Maryland, United States
Bausch Site 230
Glen Burnie, Maryland, United States
Bausch Site 132
Boston, Massachusetts, United States
Bausch Site 161
Boston, Massachusetts, United States
Bausch Site 223
Boston, Massachusetts, United States
Bausch Site 146
Burlington, Massachusetts, United States
Bausch Site 233
New Bedford, Massachusetts, United States
Bausch Site 136
Ann Arbor, Michigan, United States
Bausch Site 265
Detroit, Michigan, United States
Bausch Site 137
Detroit, Michigan, United States
Bausch Site 149
Wyoming, Michigan, United States
Bausch Site 253
Minneapolis, Minnesota, United States
Bausch Site 271
Minneapolis, Minnesota, United States
Bausch Site 148
Jackson, Mississippi, United States
Bausch Site 178
Kansas City, Missouri, United States
Bausch Site 251
East Brunswick, New Jersey, United States
Bausch Site 191
Newark, New Jersey, United States
Bausch Site 216
Albuquerque, New Mexico, United States
Bausch Site 109
New York, New York, United States
Bausch Site 225
New York, New York, United States
Bausch Site 116
New York, New York, United States
Bausch Site 217
Charlotte, North Carolina, United States
Bausch Site 192
Durham, North Carolina, United States
Bausch Site 269
Statesville, North Carolina, United States
Bausch Site 245
Wilmington, North Carolina, United States
Bausch Site 273
Wilmington, North Carolina, United States
Bausch Site 114
Cleveland, Ohio, United States
Bausch Site 154
Columbus, Ohio, United States
Bausch Site 167
Dayton, Ohio, United States
Bausch Site 185
Mentor, Ohio, United States
Bausch Site 270
Moore, Oklahoma, United States
Bausch Site 110
Philadelphia, Pennsylvania, United States
Bausch Site 228
Pittsburgh, Pennsylvania, United States
Bausch Site 250
Sayre, Pennsylvania, United States
Bausch Site 104
Charleston, South Carolina, United States
Bausch Site 184
Johnson City, Tennessee, United States
Bausch Site 181
Nashville, Tennessee, United States
Bausch Site 221
Austin, Texas, United States
Bausch Site 122
Dallas, Texas, United States
Bausch Site 144
Dallas, Texas, United States
Bausch Site 133
Dallas, Texas, United States
Bausch Site 107
Dallas, Texas, United States
Bausch Site 123
Denison, Texas, United States
Bausch Site 198
El Paso, Texas, United States
Bausch Site 172
Fort Worth, Texas, United States
Bausch Site 210
Fort Worth, Texas, United States
Bausch Site 258
Harlingen, Texas, United States
Bausch Site 170
Houston, Texas, United States
Bausch Site 130
Houston, Texas, United States
Bausch Site 158
Houston, Texas, United States
Bausch Site 159
Houston, Texas, United States
Bausch Site 229
Houston, Texas, United States
Bausch Site 239
Houston, Texas, United States
Bausch Site 252
Mesquite, Texas, United States
Bausch Site 195
Pearland, Texas, United States
Bausch Site 247
Sugar Land, Texas, United States
Bausch Site 262
Sugar Land, Texas, United States
Bausch Site 246
Texas City, Texas, United States
Bausch Site 193
Waco, Texas, United States
Bausch Site 127
Murray, Utah, United States
Bausch Site 231
Manassas, Virginia, United States
Bausch Site 175
Norfolk, Virginia, United States
Bausch Site 113
Richmond, Virginia, United States
Bausch Site 111
Richmond, Virginia, United States
Bausch Site 155
Seattle, Washington, United States
Bausch Site 105
Milwaukee, Wisconsin, United States
Bausch Site 307
Concord, New South Wales, Australia
Bausch Site 300
Kingswood, New South Wales, Australia
Bausch Site 306
Bedford Park, South Australia, Australia
Bausch Site 304
Box Hill, Victoria, Australia
Bausch Site 302
Parkville, Victoria, Australia
Bausch Site 305
Murdoch, Western Australia, Australia
Bausch Site 303
Perth, Western Australia, Australia
Bausch Site 202
Edmonton, Alberta, Canada
Bausch Site 203
Toronto, Ontario, Canada
Bausch Site 201
Toronto, Ontario, Canada
Bausch Site 234
San Juan, , Puerto Rico
Countries
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References
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Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
Other Identifiers
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RNLC3131
Identifier Type: -
Identifier Source: org_study_id
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