NCT01846663.

Study name	The efficacy, safety, and pharmacokinetics of rifaximin in subjects with severe hepatic impairment and hepatic encephalopathy.
Methods	Randomised, double‐blind (subject, caregiver, investigator, outcomes assessor), placebo controlled, parallel assignment, phase 4 trial
Participants	People in remission from overt hepatic encephalopathy and with MELD score of 19 or higher.
Interventions	Intervention: rifaximin (550 mg twice daily) Control intervention: placebo (orally administered) Duration of treatment: 6 months
Outcomes	Time to first hepatic encephalopathy (HE)‐related hospitalisation All‐cause mortality Adverse events Quality of life Laboratory markers Neurological function as assessed by the critical flicker frequency test Duration of follow‐up: 6 months
Starting date	2013
Contact information	Erica Bullock erica.bullock@salix.com Tel: 919‐862‐1854 Salix Pharmaceuticals
Notes	Country of origin: USA URL: http://clinicaltrials.gov/show/NCT01846663 Information from Salix Pharmaceuticals regarding this trial: This study is ongoing. "The recruitment is difficult due to high MELD scores requirement" received on 7 November 2016 Last update posted 1 December 2021 with an estimated primary completion date of June 2022 Data from this study, when completed, could be included in future versions of this review