Hepatic Encephalopathy (OHE)
Conditions
Brief summary
Time to first event of OHE requiring hospitalization. • A thorough evaluation of the patient will be carried out to confirm the diagnosis of OHE, which will be made by a trained medical professional (e.g., MD, DO) using American Association for the Study of Liver Disease Guidelines. • Every OHE diagnosis will be evaluated and confirmed to meet endpoint definitions by the Clinical Event Adjudication Committee (CEAC).
Detailed description
Time to first Conn score ≥ 2, Time to all-cause hospitalization, Time to first event of OHE that requires hospitalization, or all-cause death
Interventions
DRUGPlacebo
DRUGRifaximin 40 mg Soluble Solid Dispersion Immediate Release Tablets (SSD-40IR)
Sponsors
Salix Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first event of OHE requiring hospitalization. • A thorough evaluation of the patient will be carried out to confirm the diagnosis of OHE, which will be made by a trained medical professional (e.g., MD, DO) using American Association for the Study of Liver Disease Guidelines. • Every OHE diagnosis will be evaluated and confirmed to meet endpoint definitions by the Clinical Event Adjudication Committee (CEAC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first Conn score ≥ 2, Time to all-cause hospitalization, Time to first event of OHE that requires hospitalization, or all-cause death | — |
Countries
Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed