Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
- Conditions
- Hepatic Encephalopathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT05071716
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 524
- 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
- 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 (150)
Bausch Site 219
🇺🇸Atlanta, Georgia, United States
Bausch Site 140
🇺🇸Los Angeles, California, United States
Bausch Site 189
🇺🇸Los Angeles, California, United States
Bausch Site 235
🇺🇸Hollywood, Florida, United States
Bausch Site 182
🇺🇸Dothan, Alabama, United States
Bausch Site 215
🇺🇸Augusta, Georgia, United States
Bausch Site 194
🇺🇸Chicago, Illinois, United States
Bausch Site 114
🇺🇸Cleveland, Ohio, United States
Bausch Site 117
🇺🇸Baltimore, Maryland, United States
Bausch Site 255
🇺🇸Miami, Florida, United States
Bausch Site 263
🇺🇸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 218
🇺🇸Miami, Florida, United States
Bausch Site 240
🇺🇸Miami, Florida, United States
Bausch Site 161
🇺🇸Boston, Massachusetts, United States
Bausch Site 223
🇺🇸Boston, Massachusetts, United States
Bausch Site 170
🇺🇸Houston, Texas, United States
Bausch Site 130
🇺🇸Houston, Texas, United States
Bausch Site 159
🇺🇸Houston, Texas, United States
Bausch Site 238
🇺🇸Hialeah Gardens, Florida, United States
Bausch Site 220
🇺🇸Bradenton, Florida, United States
Bausch Site 249
🇺🇸Fort Myers, Florida, United States
Bausch Site 150
🇺🇸Little Rock, Arkansas, United States
Bausch Site 211
🇺🇸Homestead, Florida, United States
Bausch Site 163
🇺🇸Fresno, California, United States
Bausch Site 226
🇺🇸Chula Vista, California, United States
Bausch Site 126
🇺🇸Marietta, Georgia, United States
Bausch Site 115
🇺🇸La Jolla, California, United States
Bausch Site 103
🇺🇸Peoria, Arizona, United States
Bausch Site 199
🇺🇸Pasadena, California, United States
Bausch Site 151
🇺🇸Bristol, Connecticut, United States
Bausch Site 257
🇺🇸Cape Coral, Florida, United States
Bausch Site 139
🇺🇸Inverness, Florida, United States
Bausch Site 164
🇺🇸Bakersfield, California, United States
Bausch Site 173
🇺🇸Hialeah, Florida, United States
Bausch Site 222
🇺🇸Tucson, Arizona, United States
Bausch Site 227
🇺🇸Orange, California, United States
Bausch Site 233
🇺🇸New Bedford, Massachusetts, United States
Bausch Site 143
🇺🇸Englewood, Colorado, United States
Bausch Site 157
🇺🇸Miami, Florida, United States
Bausch Site 264
🇺🇸Miami, Florida, United States
Bausch Site 268
🇺🇸Miami, Florida, United States
Bausch Site 256
🇺🇸Plantation, Florida, United States
Bausch Site 217
🇺🇸Charlotte, North Carolina, United States
Bausch Site 191
🇺🇸Newark, New Jersey, United States
Bausch Site 110
🇺🇸Philadelphia, Pennsylvania, United States
Bausch Site 210
🇺🇸Fort Worth, Texas, United States
Bausch Site 185
🇺🇸Mentor, Ohio, United States
Bausch Site 122
🇺🇸Dallas, Texas, United States
Bausch Site 133
🇺🇸Dallas, Texas, United States
Bausch Site 123
🇺🇸Denison, Texas, United States
Bausch Site 167
🇺🇸Dayton, Ohio, United States
Bausch Site 134
🇺🇸Marrero, Louisiana, United States
Bausch Site 225
🇺🇸New York, New York, United States
Bausch Site 300
🇦🇺Kingswood, New South Wales, Australia
Bausch Site 228
🇺🇸Pittsburgh, Pennsylvania, United States
Bausch Site 239
🇺🇸Houston, Texas, United States
Bausch Site 120
🇺🇸Indianapolis, Indiana, United States
Bausch Site 260
🇺🇸Dalton, Georgia, United States
Bausch Site 251
🇺🇸East Brunswick, New Jersey, United States
Bausch Site 116
🇺🇸New York, New York, United States
Bausch Site 245
🇺🇸Wilmington, North Carolina, United States
Bausch Site 198
🇺🇸El Paso, Texas, United States
Bausch Site 252
🇺🇸Mesquite, Texas, United States
Bausch Site 195
🇺🇸Pearland, Texas, United States
Bausch Site 250
🇺🇸Sayre, Pennsylvania, United States
Bausch Site 154
🇺🇸Columbus, Ohio, United States
Bausch Site 184
🇺🇸Johnson City, Tennessee, United States
Bausch Site 234
🇵🇷San Juan, Puerto Rico
Bausch Site 135
🇺🇸Iowa City, Iowa, United States
Bausch Site 273
🇺🇸Wilmington, North Carolina, United States
Bausch Site 144
🇺🇸Dallas, Texas, United States
Bausch Site 107
🇺🇸Dallas, Texas, United States
Bausch Site 192
🇺🇸Durham, North Carolina, United States
Bausch Site 303
🇦🇺Perth, Western Australia, Australia
Bausch Site 305
🇦🇺Murdoch, Western Australia, Australia
Bausch Site 171
🇺🇸San Francisco, California, United States
Bausch Site 181
🇺🇸Nashville, Tennessee, United States
Bausch Site 180
🇺🇸Phoenix, Arizona, United States
Bausch Site 265
🇺🇸Detroit, Michigan, United States
Bausch Site 153
🇺🇸Phoenix, Arizona, United States
Bausch Site 270
🇺🇸Moore, Oklahoma, United States
Bausch Site 212
🇺🇸Littleton, Colorado, United States
Bausch Site 138
🇺🇸Jacksonville, Florida, United States
Bausch Site 224
🇺🇸Miami, Florida, United States
Bausch Site 267
🇺🇸Pembroke Pines, Florida, United States
Bausch Site 147
🇺🇸Miami, Florida, United States
Bausch Site 129
🇺🇸Chandler, Arizona, United States
Bausch Site 248
🇺🇸Tempe, Arizona, United States
Bausch Site 141
🇺🇸Lancaster, California, United States
Bausch Site 196
🇺🇸Chula Vista, California, United States
Bausch Site 174
🇺🇸Escondido, California, United States
Bausch Site 242
🇺🇸Garden Grove, California, United States
Bausch Site 214
🇺🇸San Jose, California, United States
Bausch Site 177
🇺🇸San Diego, California, United States
Bausch Site 102
🇺🇸Rialto, California, United States
Bausch Site 119
🇺🇸Redwood City, California, United States
Bausch Site 183
🇺🇸Upland, California, United States
Bausch Site 197
🇺🇸Cutler Bay, Florida, United States
Bausch Site 241
🇺🇸Lakewood Ranch, Florida, United States
Bausch Site 186
🇺🇸New Port Richey, Florida, United States
Bausch Site 272
🇺🇸Venice, Florida, United States
Bausch Site 188
🇺🇸Weston, Florida, United States
Bausch Site 152
🇺🇸Clive, Iowa, United States
Bausch Site 128
🇺🇸Topeka, Kansas, United States
Bausch Site 237
🇺🇸Baton Rouge, Louisiana, United States
Bausch Site 261
🇺🇸Houma, Louisiana, United States
Bausch Site 230
🇺🇸Glen Burnie, Maryland, United States
Bausch Site 132
🇺🇸Boston, Massachusetts, United States
Bausch Site 146
🇺🇸Burlington, Massachusetts, United States
Bausch Site 253
🇺🇸Minneapolis, Minnesota, United States
Bausch Site 137
🇺🇸Detroit, Michigan, United States
Bausch Site 271
🇺🇸Minneapolis, Minnesota, United States
Bausch Site 149
🇺🇸Wyoming, Michigan, United States
Bausch Site 148
🇺🇸Jackson, Mississippi, United States
Bausch Site 109
🇺🇸New York, New York, United States
Bausch Site 269
🇺🇸Statesville, North Carolina, United States
Bausch Site 258
🇺🇸Harlingen, Texas, United States
Bausch Site 172
🇺🇸Fort Worth, Texas, United States
Bausch Site 158
🇺🇸Houston, Texas, United States
Bausch Site 229
🇺🇸Houston, Texas, United States
Bausch Site 247
🇺🇸Sugar Land, Texas, United States
Bausch Site 193
🇺🇸Waco, Texas, United States
Bausch Site 231
🇺🇸Manassas, Virginia, United States
Bausch Site 262
🇺🇸Sugar Land, Texas, United States
Bausch Site 175
🇺🇸Norfolk, Virginia, United States
Bausch Site 127
🇺🇸Murray, Utah, United States
Bausch Site 246
🇺🇸Texas City, Texas, United States
Bausch Site 307
🇦🇺Concord, New South Wales, Australia
Bausch Site 155
🇺🇸Seattle, Washington, United States
Bausch Site 306
🇦🇺Bedford Park, South Australia, Australia
Bausch Site 304
🇦🇺Box Hill, Victoria, Australia
Bausch Site 302
🇦🇺Parkville, Victoria, Australia
Bausch Site 203
🇨🇦Toronto, Ontario, Canada
Bausch Site 201
🇨🇦Toronto, Ontario, Canada
Bausch Site 124
🇺🇸Louisville, Kentucky, United States
Bausch Site 104
🇺🇸Charleston, South Carolina, United States
Bausch Site 105
🇺🇸Milwaukee, Wisconsin, United States
Bausch Site 213
🇺🇸Orlando, Florida, United States
Bausch Site 136
🇺🇸Ann Arbor, Michigan, United States
Bausch Site 178
🇺🇸Kansas City, Missouri, United States
Bausch Site 118
🇺🇸New Orleans, Louisiana, United States
Bausch Site 221
🇺🇸Austin, Texas, United States
Bausch Site 113
🇺🇸Richmond, Virginia, United States
Bausch Site 111
🇺🇸Richmond, Virginia, United States
Bausch Site 216
🇺🇸Albuquerque, New Mexico, United States
Bausch Site 202
🇨🇦Edmonton, Alberta, Canada