Phase 3
Completed N=322
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Hepatic Encephalopathy
Source: ClinicalTrials.gov NCT00686920 ↗
Enrolled (actual)
322
Serious AEs
64.3%
Results posted
Aug 2019
Primary outcomePrimary: Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event — 78; 15; 158; 49 Participants
◆ Published Evidence
Highly cited
204citations · ~17 / year
Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy.
Summary
This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.
Linked Publications (2)
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Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy.
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Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event |
78; 15; 158; 49 | — |
| SECONDARY Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants |
15; 12; 12; 4; 18; 6 | — |
| SECONDARY Number Of Participants With A Significant Mean Change From Baseline In Vital Signs |
0; 0 | — |
| SECONDARY Change From Baseline In Conn Score At Last Assessment |
0.4; 0.2; -0.1; 0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Must sign an Informed Consent Form
- In remission from past HE
- Appropriate birth control measures
- More than or equal to 18 years of age
- Must be potential for benefit from treatment
- Recent HE episodes
- Capable and willing to comply with all study procedures
- Participant has support network
Exclusion Criteria
- Significant medical conditions or Investigator decision not to include the participant
- Allergies to the study drug or similar drugs
- Laboratory abnormalities
- Recent participation in another clinical trial
- Problems experienced in a previous HE trial
- Pregnant or at risk of pregnancy
- Recent alcohol consumption
- Active or latent bacterial or viral Infections
- Bowel issues
- Recent Active Cancer
- On a prohibited medication
Data sourced from ClinicalTrials.gov (NCT00686920) 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.