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Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:
A Multi-Center, Open-Label Trial to Evaluate the Long-Term Safety and Tolerability of Rifaximin 550 mg BID in Subjects With a History of Hepatic Encephalopathy

Clinical Trial Summary

This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.

Clinical Trial Description

Eligible participants had a history of HE, a Conn score of 0 to 2 at enrollment, and either had successfully participated in a previous HE study with rifaximin (that is, RFHE3001 [NCT00298038]), or were new participants enrolled with ≥1 verifiable episode of HE (equivalent to a Conn score of ≥2) associated with cirrhosis or portal hypertension within 12 months of screening.

Successful participation in a previous rifaximin study was defined as having received ≥80% and ≤120% of the expected tablets, having been reasonably compliant with study procedures, and having not been discontinued from the previous study due to study drug-related Adverse Events. Participants who experienced HE or associated symptoms during or after the RFHE3001 study were considered eligible for entry into this open-label study if the participant and Investigator did not perceive study medication as a possible cause of the HE episode or associated symptoms. Participants who did not participate in a previous HE study with rifaximin were eligible if this open-label study was the only rifaximin HE study available at an individual site. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00686920
Study type Interventional
Source Bausch Health Americas, Inc.
Contact
Status Completed
Phase Phase 3
Start date March 7, 2007
Completion date December 8, 2010
View Details
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