18 and older, any sex, with Hepatic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time To The First Breakthrough Overt HE EpisodePrimary· Baseline up to 6 Months (168 days)
Time to a breakthrough overt HE episode was the duration (number of days) from time of first dose of study drug to the first breakthrough overt HE episode. A breakthrough overt HE episode was defined as an increase of Conn score from Grade 0 or 1 to ≥2, or an increase in Conn and asterixis score of 1 grade each for those participants who entered the study with a Conn score of 0. Participants who completed the study and did not experience a breakthrough overt HE episode were censored at the time of their 6-month visit. Participants who terminated early for reasons other than a breakthrough over
0 to <28 Days
Group
Value
95% CI
Rifaximin
13
Placebo
20
28 to <56 Days
Group
Value
95% CI
Rifaximin
4
Placebo
23
56 to <84 Days
Group
Value
95% CI
Rifaximin
6
Placebo
14
84 to <140 Days
Group
Value
95% CI
Rifaximin
7
Placebo
10
140 to <168 Days
Group
Value
95% CI
Rifaximin
1
Placebo
6
≥168 Days
Group
Value
95% CI
Rifaximin
0
Placebo
0
Time To First HE-related HospitalizationSecondary· Baseline up to 6 months
Time to first HE-related hospitalization is defined as the duration (number of days) between the first dose of study drug and the date of first HE-related hospitalization. Participants who discontinued prior to hospitalization due to HE and prior to completion of the 6-month treatment period were censored at the time of discontinuation. The number of participants with their first HE-related hospitalization per interval is presented. The number of events of the first HE-related hospitalization during the treatment interval is presented.
0 to <28 Days
Group
Value
95% CI
Rifaximin
4
Placebo
11
28 to <56 Days
Group
Value
95% CI
Rifaximin
4
Placebo
12
56 to <84 Days
Group
Value
95% CI
Rifaximin
4
Placebo
7
84 to 140 Days
Group
Value
95% CI
Rifaximin
5
Placebo
4
140 to <168 Days
Group
Value
95% CI
Rifaximin
2
Placebo
2
≥168 Days
Group
Value
95% CI
Rifaximin
0
Placebo
0
Time To Any Increase From Baseline In Conn ScoreSecondary· Baseline up to 6 months
Time to any increase in Conn score (mental state grade) was computed as the number of days from the first dose of study drug to the initial occurrence of an increase from baseline in Conn score. Conn score range: Grade 0 (no behavioral abnormality) to Grade 4 (coma; unable to test mental state). Participants who discontinued prior to experiencing an increase in Conn score and prior to completion of the 6-month treatment period were censored at the time of discontinuation. The number of events of the initial occurrence of an increase from baseline in Conn score during the treatment interval is
0 to <28 Days
Group
Value
95% CI
Rifaximin
17
Placebo
26
28 to <56 Days
Group
Value
95% CI
Rifaximin
5
Placebo
21
56 to <84 Days
Group
Value
95% CI
Rifaximin
9
Placebo
15
84 to <140 Days
Group
Value
95% CI
Rifaximin
5
Placebo
10
140 to <168 Days
Group
Value
95% CI
Rifaximin
0
Placebo
5
≥168 Days
Group
Value
95% CI
Rifaximin
1
Placebo
0
Time To Any Increase From Baseline In Asterixis GradeSecondary· Baseline up to 6 months
Time to any increase in asterixis grade was computed as the number of days from the first dose of study drug to the initial occurrence of an increase from baseline in asterixis grade. Asterixis (flapping tremor) was determined with the participant holding both arms and forearms extended with wrists dorsiflexed and fingers open for ≥30 seconds per standard practice. Asterixis grade range: Grade 0 (no abnormal movement) to Grade 4 (almost continuous flapping motions). Participants who discontinued prior to experiencing an increase in asterixis grade and prior to completion of the 6-month treatme
0 to <28 Days
Group
Value
95% CI
Rifaximin
13
Placebo
20
28 to <56 Days
Group
Value
95% CI
Rifaximin
7
Placebo
15
56 to <84 Days
Group
Value
95% CI
Rifaximin
7
Placebo
4
84 to <140 Days
Group
Value
95% CI
Rifaximin
3
Placebo
6
140 to <168 Days
Group
Value
95% CI
Rifaximin
1
Placebo
4
≥168 Days
Group
Value
95% CI
Rifaximin
1
Placebo
1
Mean Change From Baseline In Fatigue Domain Score On The CLDQ At End Of TreatmentSecondary· Baseline, 6 months (End Of Treatment)
The 29-item Chronic Liver Disease Questionnaire (CLDQ) questionnaire consists of the following domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry. Participants ranked their level of fatigue by using a 7-point scale from the worst response (1, high degree of fatigue) to the best response (7, minimal fatigue).
Baseline
Group
Value
95% CI
Rifaximin
3.28
± 1.326
Placebo
3.34
± 1.406
Change from Baseline
Group
Value
95% CI
Rifaximin
0.30
± 1.262
Placebo
0.11
± 1.319
Mean Change From Baseline In Venous Ammonia Concentration At End Of TreatmentSecondary· Baseline, Month 6 (End Of Treatment)
Venous blood samples (10 mL) were collected at Baseline/Randomization (Day 0) and Days 28, 84, and 168. Baseline value was the last available value prior to first dose of study drug, and end of treatment value was the last available post-baseline value during the treatment period.
Baseline
Group
Value
95% CI
Rifaximin
87.9
± 47.76
Placebo
92.1
± 55.24
Change from Baseline
Group
Value
95% CI
Rifaximin
-5.7
± 46.77
Placebo
-1.2
± 60.98
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 6.5 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rifaximin
Serious: 51/140 (36%)
Deaths: —
Placebo
Serious: 63/159 (40%)
Deaths: —
Serious adverse events (84 terms)
Reaction
System
Rifaximin
Placebo
Hepatic encephalopathy
Nervous system disorders
—
—
Hepatic cirrhosis
Hepatobiliary disorders
—
—
Ascites
Gastrointestinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Oesophageal varices haemorrhage
Gastrointestinal disorders
—
—
Pneumonia
Infections and infestations
—
—
Renal failure acute
Renal and urinary disorders
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Generalised oedema
General disorders
—
—
Cellulitis
Infections and infestations
—
—
Peritonitis bacterial
Infections and infestations
—
—
Atrial fibrillation
Cardiac disorders
—
—
Cardiac failure congestive
Cardiac disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
Clostridium colitis
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Hyperkalaemia
Metabolism and nutrition disorders
—
—
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bausch Health Americas, Inc.
Last refreshed: 18 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00298038.