A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy

The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).

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