NCT01846663

Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (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 the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo, oral, 0 mg BID, 6 months of treatment
DRUG	Rifaximin	Rifaximin, oral, 550 mg BID, 6 months treatment

Timeline

• Start date: 2013-04-03
• Primary completion: 2016-02-22
• Completion: 2016-02-22
• First posted: 2013-05-03
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

28 sites across 1 country: United States