At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 222 enrolled
Drug / intervention
Rifaximin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Open-Label, Active-Controlled, Trial to Evaluate the Safety and Efficacy of Rifaximin 550 mg With and Without Lactulose in Subjects With a History of Recurrent Overt Hepatic Encephalopathy
In Brief
A Phase 4 clinical trial evaluating Rifaximin and Lactulose for Hepatic Encephalopathy and Cirrhosis. Completed, enrolled 222 participants across 43 sites.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Encephalopathy, Cirrhosis
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedApr 2013
Primary CompletionDec 2014
TodayJul 2026
First PostedApr 29, 2013
Enrollment StartJan 8, 2013
Primary CompletionDec 17, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.2 years ago
Interventions
Rifaximindrug
Rifaximin will be administered per the dose and schedule specified in the arms.
Lactulosedrug
Laculose will be administered per the schedule specified in the respective arm.