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

NCT05071716 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: RNLC3131
• Study Type: interventional
• Target: 524
• Locations: 4 countries
• Sites: 150

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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.

  72 weeks

Secondary Outcomes (3)

• Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/ clinic or death

  72 weeks

• Time to all-cause hospitalization

  72 weeks

• Time to first event of OHE that requires hospitalization, or all-cause death

  72 weeks

Study Arms (2)

Rifaximin SSD-40mg IR

EXPERIMENTAL

Drug: Rifaximin SSD

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rifaximin SSD DRUG

Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

Rifaximin SSD-40mg IR

Placebo DRUG

Placebo Twice Daily

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (150)

Bausch Site 182

Dothan, Alabama, 36301, United States

Location

Bausch Site 129

Chandler, Arizona, 85224, United States

Location

Bausch Site 103

Peoria, Arizona, 85381, United States

Location

Bausch Site 180

Phoenix, Arizona, 85013, United States

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Bausch Site 153

Phoenix, Arizona, 85054, United States

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Bausch Site 248

Tempe, Arizona, 85283, United States

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Bausch Site 222

Tucson, Arizona, 85712, United States

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Bausch Site 150

Little Rock, Arkansas, 77205, United States

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Bausch Site 164

Bakersfield, California, 93309, United States

Location

Bausch Site 196

Chula Vista, California, 91910, United States

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Bausch Site 226

Chula Vista, California, 91910, United States

Location

Bausch Site 174

Escondido, California, 92025, United States

Location

Bausch Site 163

Fresno, California, 93701, United States

Location

Bausch Site 242

Garden Grove, California, 92844, United States

Location

Bausch Site 115

La Jolla, California, 92037, United States

Location

Bausch Site 141

Lancaster, California, 93534, United States

Location

Bausch Site 140

Los Angeles, California, 90033, United States

Location

Bausch Site 189

Los Angeles, California, 90095, United States

Location

Bausch Site 227

Orange, California, 92868, United States

Location

Bausch Site 199

Pasadena, California, 91105, United States

Location

Bausch Site 119

Redwood City, California, 94063, United States

Location

Bausch Site 102

Rialto, California, 92377, United States

Location

Bausch Site 177

San Diego, California, 92114, United States

Location

Bausch Site 171

San Francisco, California, 94109, United States

Location

Bausch Site 214

San Jose, California, 95116, United States

Location

Bausch Site 183

Upland, California, 91786, United States

Location

Bausch Site 143

Englewood, Colorado, 80113, United States

Location

Bausch Site 212

Littleton, Colorado, 80120, United States

Location

Bausch Site 151

Bristol, Connecticut, 06010, United States

Location

Bausch Site 220

Bradenton, Florida, 34208, United States

Location

Bausch Site 257

Cape Coral, Florida, 33914, United States

Location

Bausch Site 197

Cutler Bay, Florida, 33157, United States

Location

Bausch Site 249

Fort Myers, Florida, 33907, United States

Location

Bausch Site 173

Hialeah, Florida, 33012, United States

Location

Bausch Site 238

Hialeah Gardens, Florida, 33016, United States

Location

Bausch Site 235

Hollywood, Florida, 33024, United States

Location

Bausch Site 211

Homestead, Florida, 33032, United States

Location

Bausch Site 139

Inverness, Florida, 34452, United States

Location

Bausch Site 138

Jacksonville, Florida, 32256, United States

Location

Bausch Site 241

Lakewood Rch, Florida, 34211, United States

Location

Bausch Site 157

Miami, Florida, 33032, United States

Location

Bausch Site 255

Miami, Florida, 33126, United States

Location

Bausch Site 263

Miami, Florida, 33144, United States

Location

Bausch Site 264

Miami, Florida, 33144, United States

Location

Bausch Site 268

Miami, Florida, 33145, United States

Location

Bausch Site 224

Miami, Florida, 33155, United States

Location

Bausch Site 243

Miami, Florida, 33156, United States

Location

Bausch Site 166

Miami, Florida, 33165, United States

Location

Bausch Site 244

Miami, Florida, 33173, United States

Location

Bausch Site 266

Miami, Florida, 33174, United States

Location

Bausch Site 147

Miami, Florida, 33176, United States

Location

Bausch Site 218

Miami, Florida, 33176, United States

Location

Bausch Site 240

Miami, Florida, 33176, United States

Location

Bausch Site 186

New Port Richey, Florida, 34653, United States

Location

Bausch Site 213

Orlando, Florida, 32803, United States

Location

Bausch Site 267

Pembroke Pines, Florida, 33027, United States

Location

Bausch Site 256

Plantation, Florida, 33317, United States

Location

Bausch Site 272

Venice, Florida, 34285, United States

Location

Bausch Site 188

Weston, Florida, 33331, United States

Location

Bausch Site 219

Atlanta, Georgia, 30342, United States

Location

Bausch Site 215

Augusta, Georgia, 30904, United States

Location

Bausch Site 260

Dalton, Georgia, 30720, United States

Location

Bausch Site 126

Marietta, Georgia, 30060, United States

Location

Bausch Site 194

Chicago, Illinois, 60612, United States

Location

Bausch Site 120

Indianapolis, Indiana, 46202, United States

Location

Bausch Site 152

Clive, Iowa, 50325, United States

Location

Bausch Site 135

Iowa City, Iowa, 52242, United States

Location

Bausch Site 128

Topeka, Kansas, 66606, United States

Location

Bausch Site 124

Louisville, Kentucky, 40202, United States

Location

Bausch Site 237

Baton Rouge, Louisiana, 70836, United States

Location

Bausch Site 261

Houma, Louisiana, 70363, United States

Location

Bausch Site 134

Marrero, Louisiana, 70072, United States

Location

Bausch Site 118

New Orleans, Louisiana, 70112, United States

Location

Bausch Site 117

Baltimore, Maryland, 21202, United States

Location

Bausch Site 230

Glen Burnie, Maryland, 21061, United States

Location

Bausch Site 132

Boston, Massachusetts, 02111, United States

Location

Bausch Site 161

Boston, Massachusetts, 02114, United States

Location

Bausch Site 223

Boston, Massachusetts, 02215, United States

Location

Bausch Site 146

Burlington, Massachusetts, 01805, United States

Location

Bausch Site 233

New Bedford, Massachusetts, 02740, United States

Location

Bausch Site 136

Ann Arbor, Michigan, 48109, United States

Location

Bausch Site 265

Detroit, Michigan, 48201, United States

Location

Bausch Site 137

Detroit, Michigan, 48202, United States

Location

Bausch Site 149

Wyoming, Michigan, 49519, United States

Location

Bausch Site 253

Minneapolis, Minnesota, 55413, United States

Location

Bausch Site 271

Minneapolis, Minnesota, 55413, United States

Location

Bausch Site 148

Jackson, Mississippi, 39216, United States

Location

Bausch Site 178

Kansas City, Missouri, 64131, United States

Location

Bausch Site 251

East Brunswick, New Jersey, 08816, United States

Location

Bausch Site 191

Newark, New Jersey, 07103, United States

Location

Bausch Site 216

Albuquerque, New Mexico, 87109, United States

Location

Bausch Site 109

New York, New York, 10021, United States

Location

Bausch Site 225

New York, New York, 10029, United States

Location

Bausch Site 116

New York, New York, 10032, United States

Location

Bausch Site 217

Charlotte, North Carolina, 28204, United States

Location

Bausch Site 192

Durham, North Carolina, 22710, United States

Location

Bausch Site 269

Statesville, North Carolina, 28635, United States

Location

Bausch Site 245

Wilmington, North Carolina, 28401, United States

Location

Bausch Site 273

Wilmington, North Carolina, 28401, United States

Location

Bausch Site 114

Cleveland, Ohio, 44106, United States

Location

Bausch Site 154

Columbus, Ohio, 43210, United States

Location

Bausch Site 167

Dayton, Ohio, 45415, United States

Location

Bausch Site 185

Mentor, Ohio, 44060, United States

Location

Bausch Site 270

Moore, Oklahoma, 73160, United States

Location

Bausch Site 110

Philadelphia, Pennsylvania, 19104, United States

Location

Bausch Site 228

Pittsburgh, Pennsylvania, 15213, United States

Location

Bausch Site 250

Sayre, Pennsylvania, 18840, United States

Location

Bausch Site 104

Charleston, South Carolina, 29425, United States

Location

Bausch Site 184

Johnson City, Tennessee, 37601, United States

Location

Bausch Site 181

Nashville, Tennessee, 37212, United States

Location

Bausch Site 221

Austin, Texas, 78750, United States

Location

Bausch Site 122

Dallas, Texas, 75024, United States

Location

Bausch Site 144

Dallas, Texas, 75203, United States

Location

Bausch Site 133

Dallas, Texas, 75216, United States

Location

Bausch Site 107

Dallas, Texas, 75246, United States

Location

Bausch Site 123

Denison, Texas, 75020, United States

Location

Bausch Site 198

El Paso, Texas, 79936, United States

Location

Bausch Site 172

Fort Worth, Texas, 76104, United States

Location

Bausch Site 210

Fort Worth, Texas, 76104, United States

Location

Bausch Site 258

Harlingen, Texas, 78550, United States

Location

Bausch Site 170

Houston, Texas, 77024, United States

Location

Bausch Site 130

Houston, Texas, 77030, United States

Location

Bausch Site 158

Houston, Texas, 77030, United States

Location

Bausch Site 159

Houston, Texas, 77030, United States

Location

Bausch Site 229

Houston, Texas, 77094, United States

Location

Bausch Site 239

Houston, Texas, 77099, United States

Location

Bausch Site 252

Mesquite, Texas, 75149, United States

Location

Bausch Site 195

Pearland, Texas, 77584, United States

Location

Bausch Site 247

Sugar Land, Texas, 77479, United States

Location

Bausch Site 262

Sugar Land, Texas, 77479, United States

Location

Bausch Site 246

Texas City, Texas, 77591, United States

Location

Bausch Site 193

Waco, Texas, 76710, United States

Location

Bausch Site 127

Murray, Utah, 84121, United States

Location

Bausch Site 231

Manassas, Virginia, 20110, United States

Location

Bausch Site 175

Norfolk, Virginia, 23502, United States

Location

Bausch Site 113

Richmond, Virginia, 23249, United States

Location

Bausch Site 111

Richmond, Virginia, 23298, United States

Location

Bausch Site 155

Seattle, Washington, 98195, United States

Location

Bausch Site 105

Milwaukee, Wisconsin, 53226, United States

Location

Bausch Site 307

Concord, New South Wales, 2139, Australia

Location

Bausch Site 300

Kingswood, New South Wales, 2750, Australia

Location

Bausch Site 306

Bedford Park, South Australia, 5042, Australia

Location

Bausch Site 304

Box Hill, Victoria, 3128, Australia

Location

Bausch Site 302

Parkville, Victoria, 3050, Australia

Location

Bausch Site 305

Murdoch, Western Australia, 6150, Australia

Location

Bausch Site 303

Perth, Western Australia, 6000, Australia

Location

Bausch Site 202

Edmonton, Alberta, T6G2R3, Canada

Location

Bausch Site 203

Toronto, Ontario, M5G 2C4, Canada

Location

Bausch Site 201

Toronto, Ontario, M6H 3M1, Canada

Location

Bausch Site 234

San Juan, 00927, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 37467180 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Mader

  Bausch Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: April 7, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CA (3); AU (7); US (139); PR (1)