RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Intervention: Rifaximin; Lactulose; Placebo
Intervention MeSH terms: Rifaximin; Lactulose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Encephalopathy, Hepatic; Portosystemic Encephalopathy; Encephalopathy, Hepatocerebral; Encephalopathy, Portal-Systemic; Encephalopathy, Portosystemic; Hepatic Coma; Hepatic Stupor; Hepatocerebral Encephalopathy; Portal-Systemic Encephalopathy

Summary:

      The purpose of this study is to compare the effectiveness of three different treatments for
      hepatic encephalopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cirrhosis of any cause

          2. History of previous admission for acute HE within 12 months of screening and Conn
             grade 0-1 HE at time of enrollment

          3. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated
             prior to any study-related activities being initiated.

          4. Subject is a male or a non-pregnant and non-lactating female. Women of
             non-childbearing potential or who are practicing adequate birth control are eligible.
             The investigator is responsible for determining whether the subject has adequate birth
             control for study participation.

          5. Subject is ≥18 years of age.

          6. Subject is capable and willing to comply with all study procedures.

          7. If the subject has a history of a portal-systemic shunt, shunt placement or revision
             must be >6 months from Screening for TIPS or a surgical shunt.

        Exclusion Criteria:

          1. Subject has a significant medical or psychiatric condition which, in the opinion of
             the Investigator, precludes participation in the study.

          2. Subject has a history of allergy or intolerance to lactulose.

          3. Subject has a history of allergy or intolerance to rifampin or rifaximin.

          4. Subject has participated in an investigational drug or device study within the 30 days
             prior to study screening.

          5. Subject is pregnant or is lactating.

          6. Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the
             Investigator.

          7. Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or
             macular degeneration) or a neurological disease beyond HE that, in the opinion of the
             Investigator, could impact their performance on neuropsychological assessments and
             psychometric tests.

          8. Subject has any condition or circumstance that would, in the opinion of the
             Investigator, prevent completion of the study or interfere with analysis of study
             results, including history of noncompliance with treatments or visits.

          9. Subject's current, required medications are on prohibited concurrent medication
             listing.

         10. Hemoglobin < 8.0 at time of screening

         11. Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental
             function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at
             time of screening

         12. Ongoing gastrointestinal bleeding at time of screening

         13. Chronic renal insufficiency with a serum creatinine > 3.0 at time of screening

         14. History of tuberculosis infection