A Phase 3 interventional study of Rifaximin SSD and Placebo in Hepatic Encephalopathy, sponsored by Bausch Health Americas, Inc.. Completed at 188 sites in 17 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Prevention
Study RNLC3132 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.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
This study's enrollment of 517 is above the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →Bausch Health Americas, Inc. is the lead sponsor of 213 studies on the registry; 7 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
First submitted after Bausch Health Americas, Inc. became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Rifaximin SSD
Drug: Placebo
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
Placebo Twice Daily
Time to First Event of Overt Hepatic Encephalopathy (OHE) Requiring Medical Intervention in the Hospital/Emergency Room (ER)/Emergency Department (ED)/Clinic or Death
The descriptive table below describes the number (in each arm/group) of Clinical Event Adjudication Committee-adjudicated events of OHE's requiring medical intervention in the hospital/ER/ED/clinic, or death. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72-week trial drug administration period.
Time to First Conn Score ≥ 2 or Confirmed Overt Hepatic Encephalopathy (OHE) Requiring Medical Intervention in the Hospital/Emergency Room (ER)/Emergency Department (ED)/Clinic or Death
The descriptive table below describes the number (in each arm/group) of participants with a Conn score ≥ 2 or a Clinical Event Adjudication Committee-adjudicated event of OHE requiring medical intervention in the hospital/ER/ED/clinic, or death were evaluated in data table below. The difference in time to this event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72-week trial drug administration period.
Time to All-cause Hospitalization
The descriptive table below describes the number (in each arm/group) of participants with an all-cause hospitalization. The difference in time to this hospitalization event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72 weeks
Time to First Event of OHE That Requires Hospitalization, or All-cause Death
The descriptive table below describes the number (in each arm/group) of participants with a first OHE event requiring hospitalization, or all-cause death. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72 weeks
Time to First Non-Overt Hepatic Encephalopathy (OHE) Complication of Cirrhosis (Composite)
The descriptive table below describes the number (composite in each arm/group) of participants with a first Non-Overt Encephalopathy (OHE) Complication of Cirrhosis: spontaneous bacterial peritonitis, acute kidney injury-hepatorenal syndrome, or esophageal variceal bleeding. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72 week trial drug administration period
Non-Overt Hepatic Encephalopathy (OHE) Complications: Spontaneous Bacterial Peritonitis (SBP) Component
The descriptive table below describes the number (in each arm/group) of participants with an event of Non-Overt Hepatic Encephalopathy (OHE) complications: spontaneous bacterial peritonitis (individual component, MedDRA PT: spontaneous bacterial peritonitis). The difference in time to this first event of SBP - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72-week trial drug administration period.
Non-Overt Hepatic Encephalopathy (OHE) Complications: Acute Kidney Injury-Hepatorenal Syndrome (AKI-HS) Component
The descriptive table below describes the number (in each arm/group) of participants with an event of the Non-Overt Hepatic Encephalopathy (OHE) complications: Acute Kidney Injury-Hepatorenal Syndrome (AKI-HS) -- individual component, MedDRA PTs: hepatorenal syndrome, hepatorenal failure. The difference in time to this first event of AKI-HS, between the two groups, is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72-week trial drug administration period.
Non-Overt Hepatic Encephalopathy (OHE) Complications: Esophageal Variceal Bleeding (EVB) Component
The descriptive table below describes the number (in each arm/group) of participants with an event of the Non-Overt Hepatic Encephalopathy (OHE) complications: Esophageal Variceal Bleeding (EVB) -- individual component, MedDRA PTs: esophageal varices hemorrhage, gastric varices hemorrhage. The difference in time to this first event of EVB, between the two groups, is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72-week trial drug administration period.
Time to All-Cause Hospitalization or All-Cause Death
The descriptive table below describes the number (in each arm/group) of participants with an event of all-cause hospitalization or all-cause death. The difference in time to the first occurrence of all-cause hospitalization or all-cause death event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72-week trial drug administration period.
Change From Baseline in Model End-Stage Liver Disease (MELD) Score
Mean value change in MELD score from baseline calculated/analyzed at Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, and 72., with the baseline mean and SD for each arm described in the data table below. MELD stands for Model End-Stage Liver Disease, and is a scoring system used in assessing the severity of Chronic Liver Disease -- it ranges from 6 to 40 as units on a scale; A lower MELD score generally indicates less severe liver disease, while a higher score reflects critical illness.
Time frame: Baseline through Week 72.
Change From Baseline in Model End-Stage Liver Disease-Sodium (MELD-Na) Score
Mean value change in MELD-Na score from baseline calculated/analyzed at Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, and 72, with the baseline mean and SD for each arm described in the data table below. The MELD-Na score stands for Model for End-Stage Liver Disease with Sodium., and is a scoring system used in assessing the severity of Chronic Liver Disease -- it ranges from 6 to 40 as units on a scale; A lower MELD-Na score generally indicates less severe liver disease, while a higher score reflects critical illness.
Time frame: Baseline through Week 72.
Changes in Animal Naming Test (ANT) Scores
Mean value change from baseline in Animal Naming Test score across scheduled postbaseline visits, with the baseline mean and SD for each arm described in the data table below. The Animal Naming Test (ANT), which serves to count the maximum number of animals a patient can name in 1 minute, is a validated tool that allows for rapid assessment of HE - with more animals named correlated with less impairment \[\<10 animals: abnormal, indicative of current or future HE; 10-14 animals: borderline range; ≥15 animals: normal performance\]. The minimum score is 0 and, while there is no theoretical maximum score, research has shown that the ANT can be a useful tool in predicting HE.
Time frame: Baseline through Week 72.
Health-Related Quality of Life: 36-item Short Form Health Survey (SF-36) and Short Form-6 Dimension (SF-6D)
Change from baseline in SF-36 summary scores (physical component summary \[PCS\], mental component summary \[MCS\]) and 8 domains, and the SF-6D utility index. Higher scores indicate better quality of life. Analyses not conducted.
Time frame: Baseline through Week 72.
Health-Related Quality of Life: PROMIS-29+2 Profile (PROPr)
Change from baseline in PROPr domain T-scores (anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities). Analyses not conducted.
Time frame: Baseline through Week 72.
Time to a 1-Point Increase From Baseline in Conn Score
The descriptive table below describes the number (in each arm/group) of participants that had a 1-Point Increase from Baseline in Conn Score. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
Time frame: 72-week trial drug administration period.
Participant recruitment for this study commenced in June 2022 and concluded in March 2024, when enrollment was officially closed.
| Milestone | Arm 1 | Arm 2 |
|---|---|---|
| Started | 255 | 262 |
| Completed | 195 | 203 |
| Not completed | 60 | 59 |
The descriptive table below describes the number (in each arm/group) of Clinical Event Adjudication Committee-adjudicated events of OHE's requiring medical intervention in the hospital/ER/ED/clinic, or death. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Time to First Event of Overt Hepatic Encephalopathy (OHE) Requiring Medical Intervention in the Hospital/Emergency Room (ER)/Emergency Department (ED)/Clinic or Death | 22 (0.48 to 1.65) | 21 (0.48 to 1.65) |
The descriptive table below describes the number (in each arm/group) of participants with a Conn score ≥ 2 or a Clinical Event Adjudication Committee-adjudicated event of OHE requiring medical intervention in the hospital/ER/ED/clinic, or death were evaluated in data table below. The difference in time to this event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Time to First Conn Score ≥ 2 or Confirmed Overt Hepatic Encephalopathy (OHE) Requiring Medical Intervention in the Hospital/Emergency Room (ER)/Emergency Department (ED)/Clinic or Death | 22 (0.48 to 1.65) | 21 (0.48 to 1.65) |
The descriptive table below describes the number (in each arm/group) of participants with an all-cause hospitalization. The difference in time to this hospitalization event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Time to All-cause Hospitalization | 57 (0.78 to 1.69) | 51 (0.78 to 1.69) |
The descriptive table below describes the number (in each arm/group) of participants with a first OHE event requiring hospitalization, or all-cause death. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Time to First Event of OHE That Requires Hospitalization, or All-cause Death | 21 (0.47 to 1.65) | 20 (0.47 to 1.65) |
The descriptive table below describes the number (composite in each arm/group) of participants with a first Non-Overt Encephalopathy (OHE) Complication of Cirrhosis: spontaneous bacterial peritonitis, acute kidney injury-hepatorenal syndrome, or esophageal variceal bleeding. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Time to First Non-Overt Hepatic Encephalopathy (OHE) Complication of Cirrhosis (Composite) | 13 (0.73 to 4.64) | 7 (0.73 to 4.64) |
The descriptive table below describes the number (in each arm/group) of participants with an event of Non-Overt Hepatic Encephalopathy (OHE) complications: spontaneous bacterial peritonitis (individual component, MedDRA PT: spontaneous bacterial peritonitis). The difference in time to this first event of SBP - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Non-Overt Hepatic Encephalopathy (OHE) Complications: Spontaneous Bacterial Peritonitis (SBP) Component | 2 (0.10 to 3.07) | 4 (0.10 to 3.07) |
The descriptive table below describes the number (in each arm/group) of participants with an event of the Non-Overt Hepatic Encephalopathy (OHE) complications: Acute Kidney Injury-Hepatorenal Syndrome (AKI-HS) -- individual component, MedDRA PTs: hepatorenal syndrome, hepatorenal failure. The difference in time to this first event of AKI-HS, between the two groups, is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Non-Overt Hepatic Encephalopathy (OHE) Complications: Acute Kidney Injury-Hepatorenal Syndrome (AKI-HS) Component | 2 (0.17 to 20.72) | 1 (0.17 to 20.72) |
The descriptive table below describes the number (in each arm/group) of participants with an event of the Non-Overt Hepatic Encephalopathy (OHE) complications: Esophageal Variceal Bleeding (EVB) -- individual component, MedDRA PTs: esophageal varices hemorrhage, gastric varices hemorrhage. The difference in time to this first event of EVB, between the two groups, is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Non-Overt Hepatic Encephalopathy (OHE) Complications: Esophageal Variceal Bleeding (EVB) Component | 9 (0.77 to 10.65) | 3 (0.77 to 10.65) |
The descriptive table below describes the number (in each arm/group) of participants with an event of all-cause hospitalization or all-cause death. The difference in time to the first occurrence of all-cause hospitalization or all-cause death event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Time to All-Cause Hospitalization or All-Cause Death | 59 (0.74 to 1.54) | 57 (0.74 to 1.54) |
Mean value change in MELD score from baseline calculated/analyzed at Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, and 72., with the baseline mean and SD for each arm described in the data table below. MELD stands for Model End-Stage Liver Disease, and is a scoring system used in assessing the severity of Chronic Liver Disease -- it ranges from 6 to 40 as units on a scale; A lower MELD score generally indicates less severe liver disease, while a higher score reflects critical illness.
| MELD Score | Arm 1 | Arm 2 |
|---|---|---|
| Change From Baseline in Model End-Stage Liver Disease (MELD) Score | 10.7 ± 3.87 | 10.9 ± 4.28 |
Mean value change in MELD-Na score from baseline calculated/analyzed at Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, and 72, with the baseline mean and SD for each arm described in the data table below. The MELD-Na score stands for Model for End-Stage Liver Disease with Sodium., and is a scoring system used in assessing the severity of Chronic Liver Disease -- it ranges from 6 to 40 as units on a scale; A lower MELD-Na score generally indicates less severe liver disease, while a higher score reflects critical illness.
| MELD-Na Score | Arm 1 | Arm 2 |
|---|---|---|
| Change From Baseline in Model End-Stage Liver Disease-Sodium (MELD-Na) Score | 12.9 ± 4.60 | 13.1 ± 5.23 |
Mean value change from baseline in Animal Naming Test score across scheduled postbaseline visits, with the baseline mean and SD for each arm described in the data table below. The Animal Naming Test (ANT), which serves to count the maximum number of animals a patient can name in 1 minute, is a validated tool that allows for rapid assessment of HE - with more animals named correlated with less impairment \[\<10 animals: abnormal, indicative of current or future HE; 10-14 animals: borderline range; ≥15 animals: normal performance\]. The minimum score is 0 and, while there is no theoretical maximum score, research has shown that the ANT can be a useful tool in predicting HE.
| Animal Naming Test (ANT) Score | Arm 1 | Arm 2 |
|---|---|---|
| Changes in Animal Naming Test (ANT) Scores | 17.1 ± 5.60 | 18.4 ± 6.87 |
Change from baseline in SF-36 summary scores (physical component summary \[PCS\], mental component summary \[MCS\]) and 8 domains, and the SF-6D utility index. Higher scores indicate better quality of life. Analyses not conducted.
Results for this outcome have not been posted.
Change from baseline in PROPr domain T-scores (anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities). Analyses not conducted.
Results for this outcome have not been posted.
The descriptive table below describes the number (in each arm/group) of participants that had a 1-Point Increase from Baseline in Conn Score. The difference in time to this first event - between the two groups - is represented by the hazard ratio described in the statistical analysis table(s) below.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Time to a 1-Point Increase From Baseline in Conn Score | 13 (0.50 to 2.41) | 12 (0.50 to 2.41) |
Collected over The on-treatment period was defined as up to 28 days after the last administration of trial drug, up to 76 weeks. The follow-up period was defined as ≥ 28 days after the last administration up to last contact, up to 80 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | 7/255 (2.7%) | 0/255 (0%) | 0/255 (0%) |
| Arm 2 | 8/262 (3.1%) | 0/262 (0%) | 0/262 (0%) |
744 participants were screened and 517 were randomized in North America, the Asian-Pacific region, and Europe.
| Age, Customized(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Equal to or less than 70 years old | 215 | 225 | 440 |
| Greater than 70 years old | 40 | 37 | 77 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 78 | 91 | 169 |
| Male | 177 | 171 | 348 |
| Race (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 41 | 43 | 84 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 6 | 9 | 15 |
| White | 197 | 199 | 396 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 10 | 10 | 20 |
| Region of Enrollment(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| United States | 119 | 120 | 239 |
| Australia | 2 | 3 | 5 |
| Belgium | 8 | 7 | 15 |
| Bulgaria | 38 | 38 | 76 |
| Canada | 3 | 4 | 7 |
| France | 5 | 6 | 11 |
| Germany | 2 | 3 | 5 |
| Hungary | 4 | 4 | 8 |
| India | 20 | 20 | 40 |
| Italy | 8 | 8 | 16 |
| South Korea | 18 | 18 | 36 |
| Mongolia | 2 | 2 | 4 |
| New Zealand | 2 | 2 | 4 |
| Poland | 7 | 7 | 14 |
| Puerto Rico | 2 | 3 | 5 |
| Spain | 11 | 11 | 22 |
| United Kingdom | 4 | 6 | 10 |
Showing the first 100 of 188 sites across 17 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bausch Health Americas, Inc. →