Trial Outcomes & Findings for Rifaximin in Minimal Hepatic Encephalopathy (NCT NCT00533910)

NCT ID: NCT00533910

Last Updated: 2020-12-17

Results Overview

Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2020-12-17

Participant Flow

Participant milestones

Measure	Placebo Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm	Rifaximin Rifaximin: 550mg BID rifaximin for 8 weeks
Overall Study STARTED	21	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rifaximin in Minimal Hepatic Encephalopathy

Baseline characteristics by cohort

Measure	Placebo n=21 Participants Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm	Rifaximin n=21 Participants Rifaximin: 550mg BID rifaximin for 8 weeks	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.

Outcome measures

Measure	Placebo n=21 Participants Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm	Rifaximin n=21 Participants Rifaximin: 550mg BID rifaximin for 8 weeks
Driving Performance	7.6 raw number of driving errors Standard Deviation 3.9	5.5 raw number of driving errors Standard Deviation 3.8

SECONDARY outcome

Timeframe: 8 weeks

Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance

Outcome measures

Measure	Placebo n=21 Participants Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm	Rifaximin n=21 Participants Rifaximin: 550mg BID rifaximin for 8 weeks
Psychometric Test Performance	0.46 Z scores Standard Deviation 0.17	1.19 Z scores Standard Deviation 0.24

SECONDARY outcome

Timeframe: 8 weeks

Total score ranging from 0 through >100 at the end of drug/placebo. Higher score indicates worse QOL

Outcome measures

Measure	Placebo n=21 Participants Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm	Rifaximin n=21 Participants Rifaximin: 550mg BID rifaximin for 8 weeks
Total Sickness Impact Profile Score	12 score on a scale Standard Deviation 3	10 score on a scale Standard Deviation 2

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rifaximin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jasmohan Bajaj

Hunter Holmes McGuire VAMC

Phone: 804 675 5802

Email: jasmohan@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place