Clinical Trial: Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief Summary: The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Detailed Summary:
Sponsor: Valeant Pharmaceuticals International, Inc.
Current Primary Outcome: Time to first Hepatic Encephalopathy(HE) breakthrough episode [ Time Frame: 6 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to first HE-related hospitalization [ Time Frame: 6 Months ]
- All Cause Mortality [ Time Frame: 6 Months ]
Original Secondary Outcome: Same as current
Information By: Valeant Pharmaceuticals International, Inc.
Dates:
Date Received: April 24, 2013
Date Started: April 3, 2013
Date Completion: June 2021
Last Updated: April 26, 2017
Last Verified: April 2017
