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Hepatic EncephalopathyPhase 3RED-C-3131NCT05071716

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

A Phase 3 study testing Rifaximin SSD in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 150 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hepatic Encephalopathy
What is being tested?
Rifaximin SSD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
524 participants
Where
150 sitesin 4 countries
Study dates
7 Apr 2022to Sep 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

150 sites in 4 countries.

150 sites in 4 countries

United States139 sites

  • Bausch Site 216

    Albuquerque, New Mexico, 87109

  • Bausch Site 136

    Ann Arbor, Michigan, 48109

  • Bausch Site 219

    Atlanta, Georgia, 30342

  • Bausch Site 215

    Augusta, Georgia, 30904

  • Bausch Site 221

    Austin, Texas, 78750

  • Bausch Site 164

    Bakersfield, California, 93309

  • Bausch Site 117

    Baltimore, Maryland, 21202

  • Bausch Site 237

    Baton Rouge, Louisiana, 70836

  • Bausch Site 132

    Boston, Massachusetts, 02111

  • Bausch Site 161

    Boston, Massachusetts, 02114

  • Bausch Site 223

    Boston, Massachusetts, 02215

  • Bausch Site 220

    Bradenton, Florida, 34208

  • Bausch Site 151

    Bristol, Connecticut, 06010

  • Bausch Site 146

    Burlington, Massachusetts, 01805

  • Bausch Site 257

    Cape Coral, Florida, 33914

  • Bausch Site 129

    Chandler, Arizona, 85224

  • Bausch Site 104

    Charleston, South Carolina, 29425

  • Bausch Site 217

    Charlotte, North Carolina, 28204

  • Bausch Site 194

    Chicago, Illinois, 60612

  • Bausch Site 196

    Chula Vista, California, 91910

  • Bausch Site 226

    Chula Vista, California, 91910

  • Bausch Site 114

    Cleveland, Ohio, 44106

  • Bausch Site 152

    Clive, Iowa, 50325

  • Bausch Site 154

    Columbus, Ohio, 43210

  • Bausch Site 197

    Cutler Bay, Florida, 33157

  • Bausch Site 122

    Dallas, Texas, 75024

  • Bausch Site 144

    Dallas, Texas, 75203

  • Bausch Site 133

    Dallas, Texas, 75216

  • Bausch Site 107

    Dallas, Texas, 75246

  • Bausch Site 260

    Dalton, Georgia, 30720

  • Bausch Site 167

    Dayton, Ohio, 45415

  • Bausch Site 123

    Denison, Texas, 75020

  • Bausch Site 265

    Detroit, Michigan, 48201

  • Bausch Site 137

    Detroit, Michigan, 48202

  • Bausch Site 182

    Dothan, Alabama, 36301

  • Bausch Site 192

    Durham, North Carolina, 22710

  • Bausch Site 251

    East Brunswick, New Jersey, 08816

  • Bausch Site 198

    El Paso, Texas, 79936

  • Bausch Site 143

    Englewood, Colorado, 80113

  • Bausch Site 174

    Escondido, California, 92025

  • Bausch Site 249

    Fort Myers, Florida, 33907

  • Bausch Site 172

    Fort Worth, Texas, 76104

  • Bausch Site 210

    Fort Worth, Texas, 76104

  • Bausch Site 163

    Fresno, California, 93701

  • Bausch Site 242

    Garden Grove, California, 92844

  • Bausch Site 230

    Glen Burnie, Maryland, 21061

  • Bausch Site 258

    Harlingen, Texas, 78550

  • Bausch Site 173

    Hialeah, Florida, 33012

  • Bausch Site 238

    Hialeah Gardens, Florida, 33016

  • Bausch Site 235

    Hollywood, Florida, 33024

  • Bausch Site 211

    Homestead, Florida, 33032

  • Bausch Site 261

    Houma, Louisiana, 70363

  • Bausch Site 170

    Houston, Texas, 77024

  • Bausch Site 130

    Houston, Texas, 77030

  • Bausch Site 158

    Houston, Texas, 77030

  • Bausch Site 159

    Houston, Texas, 77030

  • Bausch Site 229

    Houston, Texas, 77094

  • Bausch Site 239

    Houston, Texas, 77099

  • Bausch Site 120

    Indianapolis, Indiana, 46202

  • Bausch Site 139

    Inverness, Florida, 34452

  • Bausch Site 135

    Iowa City, Iowa, 52242

  • Bausch Site 148

    Jackson, Mississippi, 39216

  • Bausch Site 138

    Jacksonville, Florida, 32256

  • Bausch Site 184

    Johnson City, Tennessee, 37601

  • Bausch Site 178

    Kansas City, Missouri, 64131

  • Bausch Site 115

    La Jolla, California, 92037

  • Bausch Site 241

    Lakewood Rch, Florida, 34211

  • Bausch Site 141

    Lancaster, California, 93534

  • Bausch Site 150

    Little Rock, Arkansas, 77205

  • Bausch Site 212

    Littleton, Colorado, 80120

  • Bausch Site 140

    Los Angeles, California, 90033

  • Bausch Site 189

    Los Angeles, California, 90095

  • Bausch Site 124

    Louisville, Kentucky, 40202

  • Bausch Site 231

    Manassas, Virginia, 20110

  • Bausch Site 126

    Marietta, Georgia, 30060

  • Bausch Site 134

    Marrero, Louisiana, 70072

  • Bausch Site 185

    Mentor, Ohio, 44060

  • Bausch Site 252

    Mesquite, Texas, 75149

  • Bausch Site 157

    Miami, Florida, 33032

  • Bausch Site 255

    Miami, Florida, 33126

  • Bausch Site 263

    Miami, Florida, 33144

  • Bausch Site 264

    Miami, Florida, 33144

  • Bausch Site 268

    Miami, Florida, 33145

  • Bausch Site 224

    Miami, Florida, 33155

  • Bausch Site 243

    Miami, Florida, 33156

  • Bausch Site 166

    Miami, Florida, 33165

  • Bausch Site 244

    Miami, Florida, 33173

  • Bausch Site 266

    Miami, Florida, 33174

  • Bausch Site 147

    Miami, Florida, 33176

  • Bausch Site 218

    Miami, Florida, 33176

  • Bausch Site 240

    Miami, Florida, 33176

  • Bausch Site 105

    Milwaukee, Wisconsin, 53226

  • Bausch Site 253

    Minneapolis, Minnesota, 55413

  • Bausch Site 271

    Minneapolis, Minnesota, 55413

  • Bausch Site 270

    Moore, Oklahoma, 73160

  • Bausch Site 127

    Murray, Utah, 84121

  • Bausch Site 181

    Nashville, Tennessee, 37212

  • Bausch Site 233

    New Bedford, Massachusetts, 02740

  • Bausch Site 118

    New Orleans, Louisiana, 70112

  • Bausch Site 186

    New Port Richey, Florida, 34653

  • Bausch Site 109

    New York, New York, 10021

  • Bausch Site 225

    New York, New York, 10029

  • Bausch Site 116

    New York, New York, 10032

  • Bausch Site 191

    Newark, New Jersey, 07103

  • Bausch Site 175

    Norfolk, Virginia, 23502

  • Bausch Site 227

    Orange, California, 92868

  • Bausch Site 213

    Orlando, Florida, 32803

  • Bausch Site 199

    Pasadena, California, 91105

  • Bausch Site 195

    Pearland, Texas, 77584

  • Bausch Site 267

    Pembroke Pines, Florida, 33027

  • Bausch Site 103

    Peoria, Arizona, 85381

  • Bausch Site 110

    Philadelphia, Pennsylvania, 19104

  • Bausch Site 180

    Phoenix, Arizona, 85013

  • Bausch Site 153

    Phoenix, Arizona, 85054

  • Bausch Site 228

    Pittsburgh, Pennsylvania, 15213

  • Bausch Site 256

    Plantation, Florida, 33317

  • Bausch Site 119

    Redwood City, California, 94063

  • Bausch Site 102

    Rialto, California, 92377

  • Bausch Site 113

    Richmond, Virginia, 23249

  • Bausch Site 111

    Richmond, Virginia, 23298

  • Bausch Site 177

    San Diego, California, 92114

  • Bausch Site 171

    San Francisco, California, 94109

  • Bausch Site 214

    San Jose, California, 95116

  • Bausch Site 250

    Sayre, Pennsylvania, 18840

  • Bausch Site 155

    Seattle, Washington, 98195

  • Bausch Site 269

    Statesville, North Carolina, 28635

  • Bausch Site 247

    Sugar Land, Texas, 77479

  • Bausch Site 262

    Sugar Land, Texas, 77479

  • Bausch Site 248

    Tempe, Arizona, 85283

  • Bausch Site 246

    Texas City, Texas, 77591

  • Bausch Site 128

    Topeka, Kansas, 66606

  • Bausch Site 222

    Tucson, Arizona, 85712

  • Bausch Site 183

    Upland, California, 91786

  • Bausch Site 272

    Venice, Florida, 34285

  • Bausch Site 193

    Waco, Texas, 76710

  • Bausch Site 188

    Weston, Florida, 33331

  • Bausch Site 245

    Wilmington, North Carolina, 28401

  • Bausch Site 273

    Wilmington, North Carolina, 28401

  • Bausch Site 149

    Wyoming, Michigan, 49519

Other trials in United States

Australia7 sites

  • Bausch Site 306

    Bedford Park, South Australia, 5042

  • Bausch Site 304

    Box Hill, Victoria, 3128

  • Bausch Site 307

    Concord, New South Wales, 2139

  • Bausch Site 300

    Kingswood, New South Wales, 2750

  • Bausch Site 305

    Murdoch, Western Australia, 6150

  • Bausch Site 302

    Parkville, Victoria, 3050

  • Bausch Site 303

    Perth, Western Australia, 6000

Other trials in Australia

Canada3 sites

  • Bausch Site 202

    Edmonton, Alberta, T6G2R3

  • Bausch Site 203

    Toronto, Ontario, M5G 2C4

  • Bausch Site 201

    Toronto, Ontario, M6H 3M1

Other trials in Canada

Puerto Rico1 site

  • Bausch Site 234

    San Juan, 00927

Other trials in Puerto Rico

About this study

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 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.

Being tested
Rifaximin SSD, Placebo
Medical subject headings
Hepatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rifaximin SSDDrug

    Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

  • PlaceboDrug

    Placebo Twice Daily

Study groups in NCT05071716
Study groupRoleWhat they receive
Rifaximin SSD-40mg IRExperimentalNot described
Receives: Drug: Rifaximin SSD
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 72 weeks

Secondary outcomes (3)

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

    Measured: 72 weeks

  2. Time to all-cause hospitalization

    Measured: 72 weeks

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

    Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2021
  2. Study start7 Apr 2022
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
524 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05071716
Sponsor's protocol ID
RNLC3131
Acronym
RED-C-3131
Status last verified
Jul 2025
First submitted
28 Sep 2021
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37467180

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifaximin SSD in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 150 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Australia, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death. (time frame: 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05071716, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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