Hepatic Encephalopathy Clinical Trial
— RED-C-3131Official 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
| Verified date | March 2024 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 524 |
| Est. completion date | September 2025 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Bausch Site 306 | Bedford Park | South Australia |
| Australia | Bausch Site 304 | Box Hill | Victoria |
| Australia | Bausch Site 307 | Concord | New South Wales |
| Australia | Bausch Site 300 | Kingswood | New South Wales |
| Australia | Bausch Site 305 | Murdoch | Western Australia |
| Australia | Bausch Site 302 | Parkville | Victoria |
| Australia | Bausch Site 303 | Perth | Western Australia |
| Canada | Bausch Site 202 | Edmonton | Alberta |
| Canada | Bausch Site 201 | Toronto | Ontario |
| Canada | Bausch Site 203 | Toronto | Ontario |
| Puerto Rico | Bausch Site 234 | San Juan | |
| United States | Bausch Site 216 | Albuquerque | New Mexico |
| United States | Bausch Site 136 | Ann Arbor | Michigan |
| United States | Bausch Site 219 | Atlanta | Georgia |
| United States | Bausch Site 215 | Augusta | Georgia |
| United States | Bausch Site 221 | Austin | Texas |
| United States | Bausch Site 164 | Bakersfield | California |
| United States | Bausch Site 117 | Baltimore | Maryland |
| United States | Bausch Site 237 | Baton Rouge | Louisiana |
| 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 220 | Bradenton | Florida |
| United States | Bausch Site 151 | Bristol | Connecticut |
| United States | Bausch Site 146 | Burlington | Massachusetts |
| United States | Bausch Site 257 | Cape Coral | Florida |
| United States | Bausch Site 129 | Chandler | Arizona |
| United States | Bausch Site 104 | Charleston | South Carolina |
| United States | Bausch Site 217 | Charlotte | North Carolina |
| United States | Bausch Site 194 | Chicago | Illinois |
| United States | Bausch Site 196 | Chula Vista | California |
| United States | Bausch Site 226 | Chula Vista | California |
| United States | Bausch Site 114 | Cleveland | Ohio |
| United States | Bausch Site 152 | Clive | Iowa |
| United States | Bausch Site 154 | Columbus | Ohio |
| United States | Bausch Site 197 | Cutler Bay | Florida |
| United States | Bausch Site 107 | Dallas | Texas |
| United States | Bausch Site 122 | Dallas | Texas |
| United States | Bausch Site 133 | Dallas | Texas |
| United States | Bausch Site 144 | Dallas | Texas |
| United States | Bausch Site 260 | Dalton | Georgia |
| United States | Bausch Site 167 | Dayton | Ohio |
| United States | Bausch Site 123 | Denison | Texas |
| United States | Bausch Site 137 | Detroit | Michigan |
| United States | Bausch Site 265 | Detroit | Michigan |
| United States | Bausch Site 182 | Dothan | Alabama |
| United States | Bausch Site 192 | Durham | North Carolina |
| United States | Bausch Site 251 | East Brunswick | New Jersey |
| United States | Bausch Site 198 | El Paso | Texas |
| United States | Bausch Site 143 | Englewood | Colorado |
| United States | Bausch Site 174 | Escondido | California |
| United States | Bausch Site 249 | Fort Myers | Florida |
| United States | Bausch Site 172 | Fort Worth | Texas |
| United States | Bausch Site 210 | Fort Worth | Texas |
| United States | Bausch Site 163 | Fresno | California |
| United States | Bausch Site 242 | Garden Grove | California |
| United States | Bausch Site 230 | Glen Burnie | Maryland |
| United States | Bausch Site 258 | Harlingen | Texas |
| 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 261 | Houma | Louisiana |
| 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 170 | Houston | Texas |
| United States | Bausch Site 229 | Houston | Texas |
| United States | Bausch Site 239 | Houston | Texas |
| United States | Bausch Site 120 | Indianapolis | Indiana |
| United States | Bausch Site 139 | Inverness | Florida |
| United States | Bausch Site 135 | Iowa City | Iowa |
| United States | Bausch Site 148 | Jackson | Mississippi |
| United States | Bausch Site 138 | Jacksonville | Florida |
| United States | Bausch Site 184 | Johnson City | Tennessee |
| United States | Bausch Site 178 | Kansas City | Missouri |
| United States | Bausch Site 115 | La Jolla | California |
| United States | Bausch Site 241 | Lakewood Ranch | Florida |
| United States | Bausch Site 141 | Lancaster | California |
| United States | Bausch Site 150 | Little Rock | Arkansas |
| United States | Bausch Site 212 | Littleton | Colorado |
| United States | Bausch Site 140 | Los Angeles | California |
| United States | Bausch Site 189 | Los Angeles | California |
| United States | Bausch Site 124 | Louisville | Kentucky |
| United States | Bausch Site 231 | Manassas | Virginia |
| United States | Bausch Site 126 | Marietta | Georgia |
| United States | Bausch Site 134 | Marrero | Louisiana |
| United States | Bausch Site 185 | Mentor | Ohio |
| United States | Bausch Site 252 | Mesquite | Texas |
| United States | Bausch Site 147 | Miami | Florida |
| United States | Bausch Site 157 | Miami | Florida |
| United States | Bausch Site 166 | Miami | Florida |
| United States | Bausch Site 218 | Miami | Florida |
| United States | Bausch Site 224 | Miami | Florida |
| United States | Bausch Site 240 | Miami | Florida |
| United States | Bausch Site 243 | Miami | Florida |
| United States | Bausch Site 244 | 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 266 | Miami | Florida |
| United States | Bausch Site 268 | Miami | Florida |
| United States | Bausch Site 105 | Milwaukee | Wisconsin |
| United States | Bausch Site 253 | Minneapolis | Minnesota |
| United States | Bausch Site 271 | Minneapolis | Minnesota |
| United States | Bausch Site 270 | Moore | Oklahoma |
| United States | Bausch Site 127 | Murray | Utah |
| United States | Bausch Site 181 | Nashville | Tennessee |
| United States | Bausch Site 233 | New Bedford | Massachusetts |
| United States | Bausch Site 118 | New Orleans | Louisiana |
| United States | Bausch Site 186 | New Port Richey | Florida |
| United States | Bausch Site 109 | New York | New York |
| United States | Bausch Site 116 | New York | New York |
| United States | Bausch Site 225 | New York | New York |
| United States | Bausch Site 191 | Newark | New Jersey |
| United States | Bausch Site 175 | Norfolk | Virginia |
| United States | Bausch Site 227 | Orange | California |
| United States | Bausch Site 213 | Orlando | Florida |
| United States | Bausch Site 199 | Pasadena | California |
| United States | Bausch Site 195 | Pearland | Texas |
| United States | Bausch Site 267 | Pembroke Pines | Florida |
| United States | Bausch Site 103 | Peoria | Arizona |
| United States | Bausch Site 110 | Philadelphia | Pennsylvania |
| United States | Bausch Site 153 | Phoenix | Arizona |
| United States | Bausch Site 180 | Phoenix | Arizona |
| United States | Bausch Site 228 | Pittsburgh | Pennsylvania |
| United States | Bausch Site 256 | Plantation | Florida |
| United States | Bausch Site 119 | Redwood City | California |
| United States | Bausch Site 102 | Rialto | California |
| United States | Bausch Site 111 | Richmond | Virginia |
| United States | Bausch Site 113 | Richmond | Virginia |
| 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 250 | Sayre | Pennsylvania |
| United States | Bausch Site 155 | Seattle | Washington |
| United States | Bausch Site 269 | Statesville | North Carolina |
| United States | Bausch Site 247 | Sugar Land | Texas |
| United States | Bausch Site 262 | Sugar Land | Texas |
| United States | Bausch Site 248 | Tempe | Arizona |
| United States | Bausch Site 246 | Texas City | Texas |
| United States | Bausch Site 128 | Topeka | Kansas |
| United States | Bausch Site 222 | Tucson | Arizona |
| United States | Bausch Site 183 | Upland | California |
| United States | Bausch Site 272 | Venice | Florida |
| United States | Bausch Site 193 | Waco | Texas |
| United States | Bausch Site 188 | Weston | Florida |
| United States | Bausch Site 245 | Wilmington | North Carolina |
| United States | Bausch Site 273 | Wilmington | North Carolina |
| United States | Bausch Site 149 | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Australia, Canada, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first event of overt hepatic encephalopathy requiring hospitalization | 72 weeks | ||
| Secondary | Time to first Conn score = 2 | 72 weeks | ||
| Secondary | Time to all-cause hospitalization | 72 weeks | ||
| Secondary | Time to first event of OHE that requires hospitalization, or all-cause death | 72 weeks |
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