Phase 3
N=299
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
Hepatic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT00298038 ↗Enrolled (actual)
299
Serious AEs
38.1%
Results posted
Aug 2019
Primary outcome: Primary: Time To The First Breakthrough Overt HE Episode — 13; 20; 4; 23 events — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rifaximin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time To The First Breakthrough Overt HE Episode |
13; 20; 4; 23; 6; 14 | <0.0001 sig |
| SECONDARY Time To First HE-related Hospitalization |
4; 11; 4; 12; 4; 7 | — |
| SECONDARY Time To Any Increase From Baseline In Conn Score |
17; 26; 5; 21; 9; 15 | — |
| SECONDARY Time To Any Increase From Baseline In Asterixis Grade |
13; 20; 7; 15; 7; 4 | — |
| SECONDARY Mean Change From Baseline In Fatigue Domain Score On The CLDQ At End Of Treatment |
3.28; 3.34; 0.30; 0.11 | — |
| SECONDARY Mean Change From Baseline In Venous Ammonia Concentration At End Of Treatment |
87.9; 92.1; -5.7; -1.2 | — |
Summary
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
Eligibility Criteria
Inclusion Criteria
- Must sign an Informed Consent Form
- In remission from past HE
- Uses appropriate birth control measures
- More than or equal to 18 years of age
- Must have potential to benefit from treatment
- Recent prior HE episodes
- Capable and willing to comply with all study procedures
- Participant has personal support available
- Has a certain Model End Stage Liver Disease (MELD) score
- Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision
Exclusion Criteria
- Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to include
- Allergies to the study drug or similar drugs
- Laboratory abnormalities
- Recent participation in another clinical trial
- History of non-compliance
- Pregnant or at risk of pregnancy, or is lactating
- Recent alcohol consumption
- Active bacterial or viral Infections
- Bowel issues
- Active malignancy
- On a prohibited medication
- Liver transplant expected in near term
- Lactulose intolerance
- Participant shows presence of intestinal obstruction or has inflammatory bowel disease
- Ongoing or recent GI bleed
Data sourced from ClinicalTrials.gov (NCT00298038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.