NCT00686920

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Rifaximin	Oral

Timeline

• Start date: 2007-03-07
• Primary completion: 2010-12-08
• Completion: 2010-12-08
• First posted: 2008-05-30
• Last updated: 2019-08-14
• Results posted: 2019-08-14

Locations

35 sites across 2 countries: United States, Canada