NCT01842581

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy
• Cirrhosis

Interventions

Type	Name	Description
DRUG	Rifaximin	Rifaximin will be administered per the dose and schedule specified in the arms.
DRUG	Lactulose	Laculose will be administered per the schedule specified in the respective arm.

Timeline

• Start date: 2013-01-08
• Primary completion: 2014-12-17
• Completion: 2014-12-17
• First posted: 2013-04-29
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

43 sites across 1 country: United States