Phase 3
Completed N=299
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
Hepatic Encephalopathy
Source: ClinicalTrials.gov NCT00298038 ↗
Enrolled (actual)
299
Serious AEs
38.1%
Results posted
Aug 2019
Primary outcomePrimary: Time To The First Breakthrough Overt HE Episode — 13; 20; 4; 23 events — p=<0.0001
◆ Published Evidence
Highly cited
1,268citations · ~79 / year
Rifaximin treatment in hepatic encephalopathy.
Summary
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
Linked Publications (4)
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Rifaximin treatment in hepatic encephalopathy.
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Randomised clinical trial: rifaximin improves health-related quality of life in cirrhotic patients with hepatic encephalopathy - a double-blind placebo-controlled study.
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Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.
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Rifaximin has the potential to prevent complications of cirrhosis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.