The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
222
Number of Participants Reporting a First Breakthrough HE Episode
A breakthrough HE episode was defined as an increase of the Conn score to Grade greater than or equal to (≥) 2 (ie, 0 or 1 to ≥ 2). Conn score is widely used as a measure of mental state in HE. The scale used in Conn scoring system include: Grade 0=No personality or behavioral abnormality; Grade 1=Trivial lack of awareness, euphoria, or anxiety; shortened attention span, impairment of addition or subtraction; Grade 2=Lethargy, disorientation for time, obvious personality change, inappropriate behaviour; Grade 3=Somnolence to semi-stupor, responsive to stimuli, confused, gross disorientation, bizarre behaviour; Grade 4=Coma, unable to test mental state. The time to the first breakthrough HE episode was defined as the duration between the date of first dose of study drug and the date of first breakthrough HE episode. Number of participants reporting a first breakthrough HE episode during randomization to Month 6 is presented.
Time frame: From randomization (Day 1) up to Day 170
Number of Participants Who Were Hospitalized Due to HE Episode
An HE-related hospitalization was defined as a hospitalization directly resulting from HE, or when HE events occurred during hospitalization. The time to first HE-related hospitalization was defined as the duration between the date of first dose of study drug and the date of first HE-related hospitalization. Number of participants who were hospitalized due to HE episode during randomization to Month 6 is presented.
Time frame: From randomization (Day 1) up to Day 170
Number of Participants Who Died Due to Any Reason
Time frame: From randomization (Day 1) up to end of study (Day 186)
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Banner Research
Phoenix, Arizona, United States
Southern California Liver Centers
Coronado, California, United States
UCSF/Fresno - CRMC
Fresno, California, United States
UCSD Clinical & Translational Research Institute
La Jolla, California, United States
Salix Site
Long Beach, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Salix Site
Riverside, California, United States
Salix Site
San Diego, California, United States
Salix Site
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
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