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

Phase 4 Completed 222 enrolled Bausch Health Americas, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2013-01-08
Primary completion: 2014-12-17
Completion: 2014-12-17

Outcome

Missed primary endpoint

registry analysis (non-inferiority test); Rifaximin 550 mg BID vs Rifaximin 550 mg BID + Lactulose; p = 0.0359; Hazard Ratio (HR) 1.959 (95% CI 1.045 to 3.672); Score statistics NCT01842581 ↗

Publications

Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lactulose	Other / unclassified	—	—
Subject	Rifaximin	Other / unclassified	550 mg	Oral