Clinical trial NCT05071716: 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: 2021-10-08
Enrollment: 524
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 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: 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: Dothan
country: United States
facility: Bausch Site 182
state: Alabama
city: Chandler
country: United States
facility: Bausch Site 129
state: Arizona
city: Peoria
country: United States
facility: Bausch Site 103
state: Arizona
city: Phoenix
country: United States
facility: Bausch Site 180
state: Arizona
city: Phoenix
country: United States
facility: Bausch Site 153
state: Arizona
city: Tempe
country: United States
facility: Bausch Site 248
state: Arizona
city: Tucson
country: United States
facility: Bausch Site 222
state: Arizona
city: Little Rock
country: United States
facility: Bausch Site 150
state: Arkansas
city: Bakersfield
country: United States
facility: Bausch Site 164
state: California
city: Chula Vista
country: United States
facility: Bausch Site 196
state: California
city: Chula Vista
country: United States
facility: Bausch Site 226
state: California
city: Escondido
country: United States
facility: Bausch Site 174
state: California
city: Fresno
country: United States
facility: Bausch Site 163
state: California
city: Garden Grove
country: United States
facility: Bausch Site 242
state: California
city: La Jolla
country: United States
facility: Bausch Site 115
state: California
city: Lancaster
country: United States
facility: Bausch Site 141
state: California
city: Los Angeles
country: United States
facility: Bausch Site 140
state: California
city: Los Angeles
country: United States
facility: Bausch Site 189
state: California
city: Orange
country: United States
facility: Bausch Site 227
state: California
city: Pasadena
country: United States
facility: Bausch Site 199
state: California
city: Redwood City
country: United States
facility: Bausch Site 119
state: California
city: Rialto
country: United States
facility: Bausch Site 102
state: California
city: San Diego
country: United States
facility: Bausch Site 177
state: California
city: San Francisco
country: United States
facility: Bausch Site 171
state: California
city: San Jose
country: United States
facility: Bausch Site 214
state: California
city: Upland
country: United States
facility: Bausch Site 183
state: California
city: Englewood
country: United States
facility: Bausch Site 143
state: Colorado
city: Littleton
country: United States
facility: Bausch Site 212
state: Colorado
city: Bristol
country: United States
facility: Bausch Site 151
state: Connecticut
city: Bradenton
country: United States
facility: Bausch Site 220
state: Florida
city: Cape Coral
country: United States
facility: Bausch Site 257
state: Florida
city: Cutler Bay
country: United States
facility: Bausch Site 197
state: Florida
city: Fort Myers
country: United States
facility: Bausch Site 249
state: Florida
city: Hialeah Gardens
country: United States
facility: Bausch Site 238
state: Florida
city: Hialeah
country: United States
facility: Bausch Site 173
state: Florida
city: Hollywood
country: United States
facility: Bausch Site 235
state: Florida
city: Homestead
country: United States
facility: Bausch Site 211
state: Florida
city: Inverness
country: United States
facility: Bausch Site 139
state: Florida
city: Jacksonville
country: United States
facility: Bausch Site 138
state: Florida
city: Lakewood Ranch
country: United States
facility: Bausch Site 241
state: Florida
city: Miami
country: United States
facility: Bausch Site 157
state: Florida
city: Miami
country: United States
facility: Bausch Site 255
state: Florida
city: Miami
country: United States
facility: Bausch Site 263
state: Florida
city: Miami
country: United States
facility: Bausch Site 264
state: Florida
city: Miami
country: United States
facility: Bausch Site 268
state: Florida
city: Miami
country: United States
facility: Bausch Site 224
state: Florida
city: Miami
country: United States
facility: Bausch Site 243
state: Florida
city: Miami
country: United States
facility: Bausch Site 166
state: Florida
city: Miami
country: United States
facility: Bausch Site 244
state: Florida
city: Miami
country: United States
facility: Bausch Site 266
state: Florida
city: Miami
country: United States
facility: Bausch Site 147
state: Florida
city: Miami
country: United States
facility: Bausch Site 218
state: Florida
city: Miami
country: United States
facility: Bausch Site 240
state: Florida
city: New Port Richey
country: United States
facility: Bausch Site 186
state: Florida
city: Orlando
country: United States
facility: Bausch Site 213
state: Florida
city: Pembroke Pines
country: United States
facility: Bausch Site 267
state: Florida
city: Plantation
country: United States
facility: Bausch Site 256
state: Florida
city: Venice
country: United States
facility: Bausch Site 272
state: Florida
city: Weston
country: United States
facility: Bausch Site 188
state: Florida
city: Atlanta
country: United States
facility: Bausch Site 219
state: Georgia
city: Augusta
country: United States
facility: Bausch Site 215
state: Georgia
city: Dalton
country: United States
facility: Bausch Site 260
state: Georgia
city: Marietta
country: United States
facility: Bausch Site 126
state: Georgia
city: Chicago
country: United States
facility: Bausch Site 194
state: Illinois
city: Indianapolis
country: United States
facility: Bausch Site 120
state: Indiana
city: Clive
country: United States
facility: Bausch Site 152
state: Iowa
city: Iowa City
country: United States
facility: Bausch Site 135
state: Iowa
city: Topeka
country: United States
facility: Bausch Site 128
state: Kansas
city: Louisville
country: United States
facility: Bausch Site 124
state: Kentucky
city: Baton Rouge
country: United States
facility: Bausch Site 237
state: Louisiana
city: Houma
country: United States
facility: Bausch Site 261
state: Louisiana
city: Marrero
country: United States
facility: Bausch Site 134
state: Louisiana
city: New Orleans
country: United States
facility: Bausch Site 118
state: Louisiana
city: Baltimore
country: United States
facility: Bausch Site 117
state: Maryland
city: Glen Burnie
country: United States
facility: Bausch Site 230
state: Maryland
city: Boston
country: United States
facility: Bausch Site 132
state: Massachusetts
city: Boston
country: United States
facility: Bausch Site 161
state: Massachusetts
city: Boston
country: United States
facility: Bausch Site 223
state: Massachusetts
city: Burlington
country: United States
facility: Bausch Site 146
state: Massachusetts
city: New Bedford
country: United States
facility: Bausch Site 233
state: Massachusetts
city: Ann Arbor
country: United States
facility: Bausch Site 136
state: Michigan
city: Detroit
country: United States
facility: Bausch Site 265
state: Michigan
city: Detroit
country: United States
facility: Bausch Site 137
state: Michigan
city: Wyoming
country: United States
facility: Bausch Site 149
state: Michigan
city: Minneapolis
country: United States
facility: Bausch Site 253
state: Minnesota
city: Minneapolis
country: United States
facility: Bausch Site 271
state: Minnesota
city: Jackson
country: United States
facility: Bausch Site 148
state: Mississippi
city: Kansas City
country: United States
facility: Bausch Site 178
state: Missouri
city: East Brunswick
country: United States
facility: Bausch Site 251
state: New Jersey
city: Newark
country: United States
facility: Bausch Site 191
state: New Jersey
city: Albuquerque
country: United States
facility: Bausch Site 216
state: New Mexico
city: New York
country: United States
facility: Bausch Site 109
state: New York
city: New York
country: United States
facility: Bausch Site 225
state: New York
city: New York
country: United States
facility: Bausch Site 116
state: New York
city: Charlotte
country: United States
facility: Bausch Site 217
state: North Carolina
city: Durham
country: United States
facility: Bausch Site 192
state: North Carolina
city: Statesville
country: United States
facility: Bausch Site 269
state: North Carolina
city: Wilmington
country: United States
facility: Bausch Site 245
state: North Carolina
city: Wilmington
country: United States
facility: Bausch Site 273
state: North Carolina
city: Cleveland
country: United States
facility: Bausch Site 114
state: Ohio
city: Columbus
country: United States
facility: Bausch Site 154
state: Ohio
city: Dayton
country: United States
facility: Bausch Site 167
state: Ohio
city: Mentor
country: United States
facility: Bausch Site 185
state: Ohio
city: Moore
country: United States
facility: Bausch Site 270
state: Oklahoma
city: Philadelphia
country: United States
facility: Bausch Site 110
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Bausch Site 228
state: Pennsylvania
city: Sayre
country: United States
facility: Bausch Site 250
state: Pennsylvania
city: Charleston
country: United States
facility: Bausch Site 104
state: South Carolina
city: Johnson City
country: United States
facility: Bausch Site 184
state: Tennessee
city: Nashville
country: United States
facility: Bausch Site 181
state: Tennessee
city: Austin
country: United States
facility: Bausch Site 221
state: Texas
city: Dallas
country: United States
facility: Bausch Site 122
state: Texas
city: Dallas
country: United States
facility: Bausch Site 144
state: Texas
city: Dallas
country: United States
facility: Bausch Site 133
state: Texas
city: Dallas
country: United States
facility: Bausch Site 107
state: Texas
city: Denison
country: United States
facility: Bausch Site 123
state: Texas
city: El Paso
country: United States
facility: Bausch Site 198
state: Texas
city: Fort Worth
country: United States
facility: Bausch Site 172
state: Texas
city: Fort Worth
country: United States
facility: Bausch Site 210
state: Texas
city: Harlingen
country: United States
facility: Bausch Site 258
state: Texas
city: Houston
country: United States
facility: Bausch Site 170
state: Texas
city: Houston
country: United States
facility: Bausch Site 130
state: Texas
city: Houston
country: United States
facility: Bausch Site 158
state: Texas
city: Houston
country: United States
facility: Bausch Site 159
state: Texas
city: Houston
country: United States
facility: Bausch Site 229
state: Texas
city: Houston
country: United States
facility: Bausch Site 239
state: Texas
city: Mesquite
country: United States
facility: Bausch Site 252
state: Texas
city: Pearland
country: United States
facility: Bausch Site 195
state: Texas
city: Sugar Land
country: United States
facility: Bausch Site 247
state: Texas
city: Sugar Land
country: United States
facility: Bausch Site 262
state: Texas
city: Texas City
country: United States
facility: Bausch Site 246
state: Texas
city: Waco
country: United States
facility: Bausch Site 193
state: Texas
city: Murray
country: United States
facility: Bausch Site 127
state: Utah
city: Manassas
country: United States
facility: Bausch Site 231
state: Virginia
city: Norfolk
country: United States
facility: Bausch Site 175
state: Virginia
city: Richmond
country: United States
facility: Bausch Site 113
state: Virginia
city: Richmond
country: United States
facility: Bausch Site 111
state: Virginia
city: Seattle
country: United States
facility: Bausch Site 155
state: Washington
city: Milwaukee
country: United States
facility: Bausch Site 105
state: Wisconsin
city: Concord
country: Australia
facility: Bausch Site 307
state: New South Wales
city: Kingswood
country: Australia
facility: Bausch Site 300
state: New South Wales
city: Bedford Park
country: Australia
facility: Bausch Site 306
state: South Australia
city: Box Hill
country: Australia
facility: Bausch Site 304
state: Victoria
city: Parkville
country: Australia
facility: Bausch Site 302
state: Victoria
city: Murdoch
country: Australia
facility: Bausch Site 305
state: Western Australia
city: Perth
country: Australia
facility: Bausch Site 303
state: Western Australia
city: Edmonton
country: Canada
facility: Bausch Site 202
state: Alberta
city: Toronto
country: Canada
facility: Bausch Site 203
state: Ontario
city: Toronto
country: Canada
facility: Bausch Site 201
state: Ontario
city: San Juan
country: Puerto Rico
facility: Bausch Site 234
Study officials:
affiliation: Bausch Health
name: Michael Mader
role: STUDY_DIRECTOR
References: